Catalyft PL Expandable Interbody System recallZ-0580-2026 · Medtronic Sofamor Danek USA Inc · initiated Sep 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
FDA root cause category: Labeling design
What the company is doing
Medtronic Sofamor Danek notified consignees on about 09/16/2025 via letter. Consignees were informed of updates to the IFU and surgical guide. Consignees were instructed to share the notification within each facility with clinical users of the affected systems and to complete and return the provided Customer Acknowledgement form.
Recall details
- Recall number
- Z-0580-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 16, 2025
- Posted by the FDA
- Nov 21, 2025
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 275,260 units
- Product code
- MAX
- FDA submissions
- K210425
- Distribution
- Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Product description
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.
Code information (models, lots, serial numbers)
Show the full code information (50k characters)
IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. 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1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050584W, 1050586W, 1050590W, 1050592W, 1052420W, 1056849W, 1057484W, 1057486W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059679W, 1059681W, 1060018W, 1060042W, 1061132W, 1061136W, 1061138W, 1061140W, H5962482, H5969220, H5979175, H5979177, H5980995, H5981839, H5983795, H5991698, H5993288, H6018660, H6024652, H6030042, H6032572, H6040357, 1002451W, 1008576W, 1040457W, 1056901W, H6028216). 2. Model Number: 6068076. GTIN (Lot Numbers): 00763000246709 (0831754W, 0836194W, 0836196W, 0837729W, 0842801W, 0844113W, 0848626W, 0851984W, 0852133W, 0852135W, 0854453W, 0855324W, 0858930W, 0860486W, 0862453W, 0869639W, 0869697W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0879346W, 0879889W, 0881318W, 0881320W, 0881322W, 0881324W, 0888801W, 0891953W, 0891955W, 0891957W, 0891959W, 0891961W, 0893334W, 0895572W, 0896956W, 0896958W, 0897310W, 0900775W, 0901194W, 0902364W, 0903364W, 0904722W, 0906156W, 0907658W, 0910204W, 0910206W, 0914582W, 0917664W, 0920057W, 0920059W, 0922963W, 0924473W, 0928840W, 0929162W, 0931918W, 0933077W, 0933079W, 0933081W, 0935292W, 0935294W, 0936460W, 0937874W, 0939328W, 0940207W, 0940209W, 0941916W, 0943259W, 0943491W, 0943959W, 0947406W, 0948522W, 0948524W, 0951518W, 0952754W, 0952756W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962116W, 0962118W, 0962120W, 0962772W, 0962774W, 0967197W, 0967199W, 0967201W, 0969067W, 0973085W, 0974331W, 0974333W, 0975730W, 0976604W, 0976606W, 0976608W, 0976610W, 0976742W, 0978655W, 0978657W, 0980758W, 0980760W, 0980762W, 0983624W, 0986390W, 0989391W, 0992001W, 0992003W, 0992005W, 0992007W, 0992009W, 0993274W, 0993628W, 0993630W, 0995670W, 1002345W, 1002455W, 1002457W, 1003070W, 1003602W, 1004292W, 1004294W, 1004648W, 1004650W, 1005202W, 1007162W, 1007164W, 1007166W, 1007168W, 1007170W, 1007172W, 1007174W, 1007573W, 1007575W, 1007577W, 1007579W, 1007581W, 1007583W, 1010252W, 1010254W, 1010256W, 1010258W, 1010260W, 1010262W, 1010264W, 1010729W, 1011392W, 1011394W, 1011396W, 1011904W, 1011906W, 1013087W, 1013089W, 1013091W, 1013093W, 1013095W, 1013097W, 1013099W, 1014066W, 1014068W, 1014070W, 1014072W, 1014074W, 1014856W, 1014858W, 1014860W, 1015566W, 1015568W, 1015570W, 1015572W, 1015574W, 1015576W, 1015578W, 1016360W, 1018664W, 1018666W, 1019189W, 1019441W, 1019443W, 1019445W, 1019447W, 1019449W, 1020208W, 1020210W, 1020212W, 1020214W, 1020216W, 1020218W, 1021427W, 1021429W, 1021471W, 1021473W, 1021475W, 1021769W, 1022752W, 1024223W, 1025162W, 1026251W, 1026829W, 1027614W, 1027616W, 1027618W, 1027620W, 1028551W, 1030261W, 1031319W, 1031331W, 1031333W, 1031496W, 1031498W, 1031500W, 1031682W, 1032064W, 1032066W, 1032068W, 1032581W, 1032583W, 1032585W, 1033164W, 1033166W, 1033168W, 1033170W, 1033172W, 1033934W, 1034572W, 1034574W, 1034576W, 1034578W, 1034582W, 1034584W, 1036020W, 1036532W, 1036534W, 1036536W, 1036538W, 1036794W, 1036796W, 1036798W, 1036802W, 1041975W, 1041977W, 1041979W, 1042971W, 1043680W, 1043682W, 1043684W, 1043686W, 1043688W, 1043690W, 1044354W, 1044356W, 1044627W, 1044629W, 1044643W, 1044645W, 1044721W, 1045201W, 1045203W, 1045205W, 1045700W, 1045712W, 1045714W, 1046308W, 1046310W, 1046312W, 1046996W, 1046998W, 1047000W, 1047396W, 1047398W, 1048890W, 1048892W, 1054738W, 1054740W, 1054770W, 1054872W, 1054874W, 1055567W, 1055569W, 1055571W, 1055853W, 1055855W, 1055857W, 1056542W, 1056544W, 1056546W, 1057084W, 1057490W, 1057492W, 1057494W, 1058110W, 1067041W, H5949120, H5949481, H5953772, H5954271, H5960967, H5964111, H5964372, H5964627, H5965830, H5966104, H5968010, H5975985, H5976387, H5976389, H5976812, H5977791, H5979732, H5981967, H5982401, H5985530, H5985535, H5989329, H5990892, H5992876, H5993340, H5993606, H5994388, H5994451, H5997294, H5997295, H5997889, H5998255, H5998673, H5999512, H6000387, H6003392, H6003398, H6003403, H6004897, H6013456, H6015371, H6016681, H6020970, H6021535, H6023748, H6024154, H6024158, H6029815, H6029816, H6030132, H6030421, H6030423, H6030424, H6037256, H6040680, H6041095, H6046753, H6049447, H6049456, H6051115, H6051381, H6051486, H6051489, H6051620, H6051638, H6052354, H6054532, H6055364, H6059264, H6059280, H6060375, H6060376, H6061509, H6061801, H6061802, H6065331, H6065333, H6065334, H6066170, H6066171, H6066189, H6067518, H6067852, H6069509, H6069514, H6069738); 00763000529574 (0869639W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0881320W, 0891957W, 0896958W, 0897310W, 0928840W, 0929162W, 0933077W, 0933079W, 0933081W, 0935292W, 0943959W, 0948522W, 0948524W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962120W, 0962774W, 0975730W, 0978655W, 0980758W, 0980762W, 0986390W, 0989391W, 0992003W, 0992009W, 0993274W, 1002455W, 1003070W, 1003602W, 1005202W, 1007162W, 1007172W, 1007174W, 1007573W, 1007577W, 1010256W, 1010262W, 1011394W, 1011906W, 1031333W, 1031496W, 1031500W, 1032066W, 1032068W, 1034572W, 1034584W, 1036020W, 1036534W, 1036798W, 1043684W, 1043686W, 1044354W, 1044645W, 1045712W, 1045714W, 1057492W, H5964111, H5964627, H5997294, H5997295, H5997889, H5998255, H5999512, H6016681, 0874506W). 3. Model Number: 6068093. GTIN (Lot Numbers): 00763000246723 (0831756W, 0837731W, 0839597W, 0842803W, 0844115W, 0846535W, 0847976W, 0849550W, 0850000W, 0850415W, 0850417W, 0850842W, 0862455W, 0865723W, 0868233W, 0868235W, 0869699W, 0870553W, 0870555W, 0870557W, 0871618W, 0874997W, 0874999W, 0877439W, 0879348W, 0879891W, 0881326W, 0881328W, 0881330W, 0889938W, 0891963W, 0893336W, 0893338W, 0893340W, 0895574W, 0895576W, 0896960W, 0898382W, 0900777W, 0901196W, 0902366W, 0903366W, 0904724W, 0906158W, 0907660W, 0910208W, 0910210W, 0914584W, 0914586W, 0917666W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929164W, 0929166W, 0931920W, 0933083W, 0936462W, 0936464W, 0936466W, 0939330W, 0940211W, 0940213W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0955360W, 0955508W, 0957557W, 0957559W, 0959046W, 0959048W, 0959435W, 0959437W, 0961524W, 0967355W, 0967357W, 0967359W, 0969069W, 0973087W, 0974335W, 0974337W, 0976744W, 0976746W, 0978659W, 0980764W, 0980766W, 0980768W, 0980770W, 0982545W, 0983626W, 0983628W, 0983630W, 0984024W, 0987665W, 0987667W, 0992011W, 0992013W, 0993276W, 0999910W, 1002347W, 1002459W, 1002461W, 1002463W, 1002465W, 1003604W, 1003606W, 1004296W, 1005204W, 1008582W, 1008586W, 1008588W, 1008590W, 1008592W, 1008594W, 1008596W, 1010266W, 1010268W, 1010270W, 1010272W, 1010274W, 1010276W, 1010280W, 1011061W, 1011063W, 1011065W, 1011067W, 1011069W, 1011071W, 1011073W, 1013101W, 1013103W, 1014862W, 1014864W, 1014866W, 1014868W, 1016362W, 1020519W, 1020521W, 1021477W, 1021479W, 1021481W, 1021483W, 1021771W, 1021773W, 1021775W, 1023318W, 1023320W, 1023322W, 1023324W, 1023326W, 1024225W, 1024227W, 1024229W, 1024231W, 1024233W, 1024235W, 1024237W, 1025164W, 1025166W, 1025168W, 1025170W, 1025172W, 1026831W, 1026833W, 1026835W, 1033174W, 1033176W, 1033936W, 1033938W, 1033940W, 1033942W, 1033946W, 1033948W, 1035163W, 1035165W, 1035167W, 1035169W, 1035171W, 1036646W, 1036648W, 1036650W, 1036762W, 1036764W, 1038735W, 1051171W, 1051173W, 1051175W, 1051408W, 1051410W, 1051528W, 1051732W, 1051734W, 1051738W, 1052444W, 1052602W, 1052604W, 1053233W, 1053320W, 1054384W, 1054386W, 1054388W, 1054876W, 1054878W, 1054880W, 1054882W, 1054884W, 1055573W, 1055859W, 1056171W, 1061146W, 1062420W, 1062422W, 1062424W, 1062426W, 1063607W, 1063609W, 1063611W, 1063613W, 1063615W, 1063617W, 1063619W, 1064200W, 1064202W, 1064204W, 1064206W, 1064208W, 1064210W, 1064212W, 1065480W, 1065482W, 1065484W, 1065886W, 1065888W, 1066276W, 1067043W, 1067047W, 1067049W, 1067051W, 1067731W, 1067735W, 1068328W, 1069186W, 1070532W, H5967258, H5967772, H5969833, H5971306, H5974320, H5978126, H5979314, H5980562, H5985536, H5986047, H5989315, H5991474, H5993603, H5995533, H5996160, H5998668, H5998674, H5999515, H6000802, H6002928, H6005532, H6008224, H6008227, H6008684, H6008687, H6011078, H6017927, H6018624, H6021750, H6022943, H6023883, H6024773, H6024777, H6028242, H6028244, H6028247, H6030174, H6031557, H6031560, H6031562, H6036195, H6041821); 00763000529581 (0868233W, 0869699W, 0870553W, 0870555W, 0870557W, 0881326W, 0881328W, 0895574W, 0895576W, 0898382W, 0902366W, 0904724W, 0906158W, 0907660W, 0910210W, 0914586W, 0920061W, 0920063W, 0922035W, 0922037W, 0922965W, 0924475W, 0929166W, 0931920W, 0933083W, 0944351W, 0947408W, 0948526W, 0950152W, 0951520W, 0952758W, 0952760W, 0954070W, 0954072W, 0955358W, 0957559W, 0959046W, 0959048W, 0969069W, 0974335W, 0974337W, 0980766W, 0980770W, 0982545W, 0983626W, 0983628W, 0987665W, 0992011W, 0993276W, 1002459W, 1002461W, 1002463W, 1002465W, 1005204W, 1008582W, 1008586W, 1008590W, 1008594W, 1008596W, 1010272W, 1010276W, 1011065W, 1021481W, 1021483W, 1023318W, 1023326W, 1025164W, 1025166W, 1026835W, 1033176W, 1033938W, 1033940W, 1035171W, 1036764W, 1051408W, 1051410W, 1051738W, 1052604W, 1053233W, 1053320W, 1054386W, 1054388W, 1054878W, 1054880W, 1054882W, 1055573W, 1061146W, 1062422W, H5967258, H5974320, H5978126, H5980562, H5991474, H6000802, H6008687, H6021750, H6028244, H6031557, H6031562, 0871616W, 1033944W, 1052442W); N/A (1008592W). 4. Model Number: 6068096. GTIN (Lot Numbers): 00763000246730 (0831758W, 0836198W, 0836200W, 0836202W, 0837733W, 0842805W, 0844111W, 0848628W, 0849622W, 0852137W, 0852139W, 0854455W, 0855326W, 0860488W, 0860490W, 0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0881332W, 0885962W, 0885964W, 0887344W, 0887346W, 0887348W, 0888803W, 0889940W, 0891965W, 0893342W, 0893344W, 0898384W, 0900779W, 0901198W, 0901200W, 0902368W, 0903368W, 0904726W, 0906160W, 0907662W, 0910212W, 0910214W, 0914588W, 0914590W, 0917668W, 0920065W, 0920067W, 0924477W, 0929168W, 0929170W, 0931962W, 0935296W, 0935298W, 0935300W, 0936468W, 0937876W, 0937878W, 0939332W, 0940215W, 0940217W, 0942914W, 0943493W, 0945703W, 0947410W, 0948528W, 0950154W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0955510W, 0957561W, 0957563W, 0959050W, 0959052W, 0959439W, 0959441W, 0959443W, 0961526W, 0961528W, 0967361W, 0968362W, 0968364W, 0968366W, 0969281W, 0973089W, 0974339W, 0974341W, 0976748W, 0977732W, 0986512W, 0987044W, 0987046W, 0987669W, 0988253W, 0988255W, 0988257W, 0989571W, 0989573W, 0990966W, 0992015W, 1002467W, 1002469W, 1002471W, 1002619W, 1003608W, 1003610W, 1003612W, 1003614W, 1004298W, 1004300W, 1004302W, 1004304W, 1004306W, 1004308W, 1004312W, 1004314W, 1005206W, 1005208W, 1006070W, 1006262W, 1007176W, 1007178W, 1007180W, 1007182W, 1007585W, 1007587W, 1007589W, 1007591W, 1007593W, 1007595W, 1007597W, 1007599W, 1007601W, 1009619W, 1010501W, 1010503W, 1010505W, 1010507W, 1011398W, 1011400W, 1011908W, 1011910W, 1012758W, 1013105W, 1016364W, 1016366W, 1016368W, 1016370W, 1016372W, 1016374W.1016376W, 1017298W, 1017477W, 1017479W, 1017531W, 1017533W, 1017535W, 1017537W, 1017539W, 1018238W, 1018240W, 1018668W, 1018670W, 1018672W, 1018674W, 1018676W, 1018678W, 1018680W, 1018682W, 1019451W, 1019453W, 1019455W, 1020220W, 1020222W, 1020523W, 1020525W, 1021485W, 1021777W, 1022754W, 1022756W, 1022758W, 1022760W, 1023328W, 1023330W, 1024239W, 1024241W, 1024243W, 1026253W, 1031335W, 1031684W, 1031686W, 1031688W, 1032070W, 1032587W, 1032589W, 1033178W, 1033950W, 1034586W, 1035173W, 1036546W, 1036548W, 1036550W, 1036552W, 1037697W, 1037699W, 1037701W, 1037703W, 1037705W, 1037707W, 1037709W, 1037711W, 1038216W, 1038218W, 1038737W, 1039196W, 1039198W, 1047402W, 1047404W, 1048896W, 1048898W, 1048900W, 1049718W, 1049720W, 1049724W, 1049726W, 1049728W, 1049730W, 1049732W, 1049734W, 1050594W, 1050596W, 1050600W, 1051177W, 1051179W, 1058112W, 1058114W, 1058813W, 1058815W, 1058817W, 1059287W, 1059289W, 1060044W, 1060046W, 1060048W, 1060764W, 1060766W, 1060768W, 1060770W, 1060772W, 1067053W, 1067737W, 1068330W, 1068332W, H5956283, H5960953, H5964135, H5965898, H5966475, H5970317, H5970760, H5984641, H5989733, H5991687, H5991705, H5991988, H5993392, H5995463, H5998258, H5998282, H6004896, H6009876, H6010856, H6011481, H6012334, H6012339, H6012341, H6012342, H6015369, H6016337, H6021548, H6021637, H6021638, H6022792, H6037264, H6040370, H6044520, H6044521, H6046120, H6048318, H6049015, H6049835, H6049839, H6049845, H6051267, H6052448, H6053451, H6054112, H6055379, H6056422, H6056423, H6060611, H6066196, H6066198, H6067909, H6067910); 00763000529598(0862457W, 0864032W, 0864038W, 0871620W, 0872100W, 0873208W, 0881015W, 0898384W, 0902368W, 0903368W, 0935296W, 0935300W, 0937878W, 0939332W, 0943493W, 0951522W, 0952762W, 0952764W, 0954074W, 0954076W, 0955362W, 0955364W, 0957561W, 0959050W, 0959052W, 0959441W, 0973089W, 0988257W, 0989571W, 1003610W, 1003612W, 1007182W, 1050596W, 1051177W, 0864036W, 0873210W, 1004310W, 1007184W); N/A (1017479W). 5. Model Number: 6068113. GTIN (Lot Numbers): 00763000246754 (0831760W, 0836204W, 0837735W, 0839599W, 0841051W, 0842331W, 0844117W, 0846537W, 0847978W, 0849572W, 0849574W, 0868237W, 0870559W, 0874510W, 0879893W, 0885966W, 0887350W, 0888805W, 0896962W, 0898386W, 0900781W, 0901202W, 0902370W, 0903370W, 0905342W, 0910216W, 0922967W, 0924479W, 0927268W, 0929172W, 0939334W, 0951524W, 0952501W, 0952766W, 0954078W, 0957565W, 0957567W, 0961530W, 0962776W, 0968368W, 0969283W, 0973091W, 0976750W, 0977734W, 0995692W, 0997492W, 0997494W, 0997496W, 0999005W, 1000102W, 1002992W, 1006264W, 1031690W, 1032322W, 1032591W, 1033180W, 1033182W, 1033184W, 1033186W, 1033188W, 1033190W, 1033952W, 1033954W, 1041300W, 1041302W, 1041981W, 1041983W, 1041985W, 1041987W, 1042973W, 1042975W, 1042977W, 1042979W, 1043692W, 1050520W, 1051181W, 1052606W, 1052608W, 1064945W, 1064947W, 1067055W, 1067059W, H5959856, H5960023, H5976169, H5979255, H5980559, H5982391, H5995538, H5997547, H6018332, H6024477, H6030932, H6031564, H6035714, H6046424); 00763000529604 (0836204W, 0849572W, 0868237W, 0870559W, 0874510W, 0885966W, 0888805W, 0896962W, 0900781W, 0922967W, 0924479W, 0927268W, 0929172W, 0951524W, 0952766W, 0957565W, 0957567W, 0961530W, 0973091W, 0976750W, 1000102W, 1031690W, 1032591W, 1033954W, 1041300W, 1041981W, 1041983W, 1041987W, 1042977W, 1042979W, 1043692W, H5976169, H5980559, H5997547, 0854457W, 0857971W). 6. Model Number: 6068116. GTIN (Lot Numbers): 00763000246761 (0831762W, 0837093W, 0837737W, 0845005W, 0845007W, 0850844W, 0853143W, 0854459W, 0858932W, 0861112W, 0862459W, 0864040W, 0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0888807W, 0891967W, 0893346W, 0896964W, 0896966W, 0898388W, 0905344W, 0906452W, 0910218W, 0914592W, 0914594W, 0920069W, 0926363W, 0927270W, 0929174W, 0931964W, 0937880W, 0939336W, 0942916W, 0943495W, 0945705W, 0951526W, 0952503W, 0952768W, 0952770W, 0955366W, 0957569W, 0957571W, 0959054W, 0964248W, 0964250W, 0965516W, 0973093W, 0976752W, 0976754W, 0976756W, 0977736W, 0978661W, 0983632W, 0987048W, 0989575W, 0994928W, 0995694W, 1011075W, 1011402W, 1012052W, 1012054W, 1012056W, 1012058W, 1012760W, 1012762W, 1012764W, 1012766W, 1013107W, 1013109W, 1013111W, 1013113W, 1013115W, 1013117W, 1013119W, 1013121W, 1014076W, 1016378W, 1016380W, 1016382W, 1039200W, 1039202W, 1039822W, 1039824W, 1040470W, 1040492W, 1040633W, 1040635W, 1040637W, 1040639W, 1040641W, 1041304W, 1041306W, 1041308W, 1041989W, 1041991W, 1041993W, 1041995W, 1041997W, 1051522W, 1052610W, 1053235W, 1053237W, 1053239W, 1053342W, 1054390W, 1054392W, 1054394W, 1061148W, 1061150W, 1062428W, 1062430W, 1062432W, 1066280W, 1066282W, 1066284W, H5969398, H5972674, H5975979, H5976386, H5976707, H5979718, H5985104, H5991292, H5993488, H5996970, H6007862, H6011074, H6015364, H6022791, H6025215, H6025218, H6042906, H6043292, H6050290, H6051116, H6053616, H6055646); 00763000529611 (0874512W, 0875981W, 0881017W, 0881334W, 0881336W, 0891967W, 0898388W, 0905344W, 0929174W, 0952770W, 0957569W, 0957571W, 0959054W, 0964248W, 0965516W, 0977736W, 0987048W, 0989575W, 0994928W, 0995694W, 1013111W, 1039200W, 1053237W, 1054392W, 1061148W, H5972674, H5976707, H5985104, 0874514W). 7. Model Number: 6069073. GTIN (Lot Numbers): 00763000246785 (0831764W, 0837739W, 0837741W, 0839601W, 0839603W, 0842333W, 0849576W, 0853145W, 0854461W, 0855328W, 0857973W, 0858934W, 0862491W, 0865725W, 0874361W, 0875983W, 0877441W, 0879350W, 0879352W, 0885968W, 0887352W, 0888809W, 0889942W, 0891969W, 0896968W, 0898390W, 0900783W, 0901204W, 0901206W, 0902372W, 0903372W, 0905346W, 0907664W, 0917670W, 0917672W, 0918868W, 0918870W, 0918872W, 0918874W, 0920071W, 0920073W, 0922039W, 0922969W, 0924481W, 0939338W, 0942918W, 0943497W, 0943499W, 0945707W, 0951528W, 0952505W, 0952507W, 0952772W, 0952774W, 0955368W, 0957573W, 0960500W, 0962778W, 0962780W, 0964632W, 0965518W, 0968370W, 0969285W, 0969287W, 0976758W, 0977738W, 0978663W, 0978665W, 0983634W, 0989577W, 0989579W, 0992017W, 0993278W, 0993682W, 0994333W, 0994335W, 0994930W, 0995696W, 0999007W, 1003616W, 1003618W, 1004316W, 1004318W, 1004320W, 1007186W, 1007188W, 1009437W, 1009441W, 1009443W, 1009447W, 1009449W, 1009451W, 1009453W, 1011404W, 1011406W, 1011408W, 1011410W, 1011412W, 1011414W, 1011416W, 1012060W, 1012062W, 1012064W, 1017300W, 1017302W, 1017304W, 1017306W, 1017308W, 1017310W, 1017312W, 1018242W, 1018244W, 1018246W, 1018248W, 1018250W, 1019457W, 1019459W, 1019461W, 1019463W, 1019465W, 1019467W, 1019469W, 1035175W, 1036766W, 1036768W, 1036770W, 1036772W, 1036774W, 1036776W, 1037713W, 1037715W, 1038220W, 1038222W, 1038224W, 1038226W, 1038739W, 1038951W, 1038953W, 1038955W, 1039206W, 1039208W, 1039210W, 1039826W, 1039828W, 1039830W, 1040494W, 1040496W, 1040498W, 1040643W, 1040645W, 1040647W, 1040649W, 1048902W, 1048904W, 1048906W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050602W, 1050604W, 1050608W, 1050610W, 1050612W, 1050614W, 1051183W, 1051185W, 1051187W, 1051741W, 1051743W, 1057496W, 1058116W, 1058118W, 1058120W, 1058819W, 1058821W, 1058823W, 1058825W, 1058827W, 1058829W, 1059130W, 1060050W, 1060052W, 1060054W, 1060056W, 1060058W, 1060060W, 1060062W, 1064951W, 1065486W, 1065488W, 1065490W, 1065492W, 1065494W, 1065496W, 1065890W, 1065892W, 1065894W, 1066286W, 1066288W, 1067743W, 1067745W, 1067747W, 1067749W, 1071981W, 1071983W, 1071985W, 1071989W, H5960025, H5961680, H5962675, H5963063, H5964483, H5964903, H5966153, H5967526, H5974499, H5975996, H5976681, H5979308, H5984607, H5984805, H5985111, H5993303, H5995219, H5997146, H5997325, H6000119, H6009907, H6010342, H6010848, H6015956, H6015957, H6018341, H6018345, H6018346, H6018349, H6022886, H6022887, H6024860, H6024863, H6027581, H6028240, H6033629, H6036553, H6042589); 00763000868963 (0977738W, 0993682W, 0994335W, 0995696W, 0999007W, 1003618W, 1007186W, 1009443W, 1009447W, 1009449W, 1009453W, 1011410W, 1011412W, 1017306W, 1018242W, 1018250W, 1036774W, 1037713W, 1037715W, 1038220W, 1038224W, 1038226W, 1038739W, 1038953W, 1038955W, 1039206W, 1039208W, 1040496W, 1040498W, 1048904W, 1049736W, 1049738W, 1049740W, 1049742W, 1049744W, 1050608W, H5964903, H5966153, H5984805, H6000119, H6009907, H6010342, 1009439W, 1050606W). 8. Model Number: 6069076. GTIN (Lot Number): 00763000246792 (0831766W, 0836206W, 0837743W, 0839605W, 0839607W, 0842335W, 0842807W, 0854463W, 0856700W, 0857975W, 0861114W, 0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0881019W, 0885970W, 0885972W, 0887354W, 0887356W, 0895578W, 0896970W, 0898392W, 0900785W, 0903374W, 0905348W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0918878W, 0920075W, 0926365W, 0926367W, 0927302W, 0931966W, 0935302W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0960504W, 0965520W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0995142W, 0995698W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1005210W, 1006266W, 1007190W, 1009455W, 1009457W, 1009459W, 1012768W, 1012770W, 1012772W, 1014078W, 1014080W, 1014082W, 1014084W, 1014086W, 1014088W, 1024245W, 1024247W, 1024249W, 1025174W, 1025176W, 1025178W, 1025180W, 1025182W, 1025184W, 1026255W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1040651W, 1040653W, 1040655W, 1041310W, 1041312W, 1041314W, 1041316W, 1041318W, 1041999W, 1042001W, 1042981W, 1042983W, 1042985W, 1042987W, 1042989W, 1042991W, 1042993W, 1043694W, 1043696W, 1051524W, 1051526W, 1053681W, 1053683W, 1054742W, 1054744W, 1054890W, 1054892W, 1056173W, 1056175W, 1056548W, 1056550W, 1056552W, 1057086W, 1057498W, 1057500W, 1057502W, 1058122W, 1058124W, 1063621W, 1063623W, 1064953W, 1064955W, 1064957W, 1064959W, 1064961W, 1067755W, 1067757W, H5956358, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H5993941, H5995547, H5996600, H6002559, H6017939, H6018616, H6018617, H6018618, H6028231, H6030562, H6038010, H6038011, H6038861, H6038924, H6038927, H6041814, H6046740, H6046744, H6052034, H6052339, H6052342, H6052344, H6053190, H6054116, H6054120, H6055676, H6057303); 00763000529628 (0862493W, 0865727W, 0869721W, 0870561W, 0870563W, 0870565W, 0875985W, 0895578W, 0896970W, 0898392W, 0900785W, 0906456W, 0907666W, 0910220W, 0910222W, 0914596W, 0914598W, 0917674W, 0918876W, 0920075W, 0926365W, 0927302W, 0931966W, 0935304W, 0937882W, 0937884W, 0939340W, 0942920W, 0947412W, 0947414W, 0948530W, 0950156W, 0951530W, 0954080W, 0957575W, 0959056W, 0959058W, 0959060W, 0960502W, 0969289W, 0973095W, 0974343W, 0976760W, 0976762W, 0977740W, 0982547W, 0982549W, 0997498W, 0997500W, 0997502W, 0998721W, 0999009W, 1000782W, 1000784W, 1002349W, 1002351W, 1002353W, 1002355W, 1002357W, 1009459W, 1012772W, 1024249W, 1025176W, 1025178W, 1025182W, 1025184W, 1026257W, 1026259W, 1026261W, 1030263W, 1032593W, 1032595W, 1033192W, 1041310W, 1041316W, 1041318W, 1041999W, 1042001W, 1042991W, 1043694W, 1043696W, 1054742W, 1054744W, 1054890W, 1054892W, 1056548W, 1057498W, H5973087, H5975978, H5976695, H5977790, H5979741, H5980568, H6017939, H6018616, H6018617, H6018618, 0871642W, 0957577W, 1012774W, 1033194W, 1054888W). 9. Model Number: 6069093. GTIN (Lot Numbers): 00763000246815 (0835085W, 0836208W, 0839609W, 0841053W, 0842337W, 0844119W, 0847980W, 0848630W, 0854465W, 0857977W, 0858936W, 0861116W, 0864042W, 0864598W, 0865729W, 0868239W, 0868241W, 0868243W, 0870567W, 0874516W, 0877443W, 0885974W, 0887358W, 0887360W, 0896972W, 0898394W, 0901208W, 0905350W, 0906458W, 0910224W, 0910226W, 0918880W, 0918882W, 0920077W, 0922081W, 0923071W, 0924483W, 0951532W, 0952509W, 0954082W, 0957579W, 0957581W, 0961532W, 0962782W, 0964634W, 0969291W, 0977742W, 0977744W, 0978667W, 0982551W, 0995144W, 0995700W, 0997504W, 0998723W, 1000252W, 1005212W, 1011418W, 1012066W, 1012068W, 1012776W, 1012778W, 1014090W, 1014092W, 1014094W, 1014096W, 1014098W, 1014100W, 1023332W, 1023334W, 1024082W, 1027622W, 1027624W, 1027626W, 1027628W, 1027630W, 1028555W, 1028708W, 1028710W, 1028992W, 1028994W, 1029482W, 1029484W, 1030265W, 1031692W, 1043698W, 1043700W, 1044358W, 1044360W, 1044362W, 1044364W, 1044366W, 1045207W, 1051189W, 1060774W, 1060780W, 1060782W, 1061152W, 1061154W, 1061156W, 1061158W, 1062434W, 1062436W, 1062438W, 1063625W, 1063627W, 1063631W, 1063633W, 1064963W, 1064965W, 1064967W, 1065898W, 1065900W, 1066290W, 1068334W, 1073942W, H5960042, H5961689, H5967799, H5974501, H5974933, H5975083, H5979715, H5980972, H5991983, H5993359, H6000395, H6004895, H6010721, H6015923, H6020628, H6030549, H6031668, H6032600, H6034517, H6042892); 00763000868970 (0962782W, 0977742W, 0978667W, 0998723W, 1000252W, 1005212W, 1012068W, 1023332W, 1023334W, 1024082W, 1027624W, 1027626W, 1027628W, 1027630W, 1028555W, 1029482W, 1043698W, 1043700W, 1060780W, 1061154W, H5960042, H5961689, H6020628, H6030549, H6031668). 10. Model Number: 6069096. GTIN (Lot Number): 00763000246822 (0831770W, 0836210W, 0837745W, 0839611W, 0842809W, 0845009W, 0848632W, 0853147W, 0854467W, 0857979W, 0861118W, 0865791W, 0868245W, 0868247W, 0871644W, 0872382W, 0873212W, 0873214W, 0874518W, 0885976W, 0885978W, 0893348W, 0895580W, 0895582W, 0896974W, 0898396W, 0900787W, 0901210W, 0906460W, 0907668W, 0910228W, 0910230W, 0914600W, 0918884W, 0920079W, 0927304W, 0931968W, 0933821W, 0937886W, 0939342W, 0942922W, 0945709W, 0947416W, 0948532W, 0951534W, 0954084W, 0957583W, 0957585W, 0959062W, 0960506W, 0962784W, 0964636W, 0965522W, 0969293W, 0969295W, 0969297W, 0978669W, 0982553W, 0982555W, 0985588W, 0986514W, 0987050W, 0987092W, 0987094W, 0999663W, 1000254W, 1000786W, 1000788W, 1002359W, 1002994W, 1005214W, 1005216W, 1005218W, 1005220W, 1005222W, 1005224W, 1006268W, 1012070W, 1012072W, 1012782W, 1012784W, 1014102W, 1014104W, 1014106W, 1014108W, 1028557W, 1028559W, 1029486W, 1029488W, 1029490W, 1029492W, 1029494W, 1029496W, 1030267W, 1030269W, 1031337W, 1031339W, 1031341W, 1031343W, 1031345W, 1031694W, 1031696W, 1045209W, 1045716W, 1046314W, 1046316W, 1046318W, 1047002W, 1047004W, 1047406W, 1047408W, 1047410W, 1048908W, 1048910W, 1048912W, 1056177W, 1057088W, 1057090W, 1057092W, 1057094W, 1057504W, 1057506W, 1057508W, 1057510W, 1057512W, 1057514W, 1058130W, 1058132W, 1058134W, 1058136W, 1058138W, 1058140W, 1058142W, 1067769W, 1067771W, H5955974, H5957168, H5957396, H5964622, H5966358, H5969388, H5979722, H5989742, H5992479, H5996166, H5999506, H6006140, H6006301, H6006302, H6012911, H6016714, H6022795, H6022796, H6032586, H6032593, H6034856, H6037626, H6038100, H6042230, H6046751, H6046819, H6050756, H6059214, H6059215, H6061709); 00763000529635 (0868245W, 0868247W, 0871644W, 0872382W, 0873212W, 0873214W, 0893348W, 0895580W, 0896974W, 0906460W, 0910228W, 0918884W, 0927304W, 0931968W, 0939342W, 0942922W, 0948532W, 0951534W, 0954084W, 0957583W, 0959062W, 0960506W, 0962784W, 0965522W, 0969293W, 0969297W, 0978669W, 0982553W, 0982555W, 0985588W, 0986514W, 0987050W, 0987092W, 0987094W, 0999663W, 1000786W, 1000788W, 1002359W, 1006268W, 1028559W, 1029486W, 1029494W, 1030269W, 1031339W, 1031343W, 1031694W, 1031696W, 1047408W, 1047410W, 1056177W, 1057092W, 1058138W, H5966358, H6006140, H6022795, H6022796, 0954086W). 11. Model Number: 6069113. GTIN (Lot Numbers): 00763000246846 (0831772W, 0837747W, 0839629W, 0842339W, 0845011W, 0848634W, 0853149W, 0856702W, 0857981W, 0861120W, 0877445W, 0885980W, 0900789W, 0900791W, 0901212W, 0906462W, 0910232W, 0922083W, 0939344W, 0954088W, 0961534W, 0969299W, 0973097W, 0993280W, 0995702W, 0995704W, 0998725W, 0998727W, 0999021W, 1000256W, 1039832W, 1039834W, 1039836W, 1041320W, 1041322W, 1041324W, 1042005W, 1054396W, 1054398W, 1056554W, H5971934, H5976295, H5992850, H5993910, H6005118, H6005120, H6025184, H6026751); 00763000868987 (0969299W, 0973097W, 0993280W, 0995702W, 0995704W, 0998725W, 0998727W). 12. Model Number: 6069116. GTIN (Lot Numbers): 00763000246853 (0831774W, 0836212W, 0842341W, 0845013W, 0858938W, 0865793W, 0871070W, 0875987W, 0881338W, 0885982W, 0888811W, 0893350W, 0895584W, 0898398W, 0900793W, 0901214W, 0906464W, 0914602W, 0914604W, 0927306W, 0931970W, 0939346W, 0951536W, 0954090W, 0954092W, 0962786W, 0964638W, 0969301W, 0973099W, 0976764W, 0993684W, 0995146W, 0995706W, 0997506W, 0998729W, 1000211W, 1014110W, 1014870W, 1014872W, 1014874W, 1014876W, 1030271W, 1032324W, 1033196W, 1033956W, 1034588W, 1039838W, 1039840W, 1040657W, 1052448W, 1052612W, 1052614W, 1053685W, 1054746W, 1060784W, 1060786W, 1066292W, 1066294W, 1067773W, H5975982, H5978965, H5991291, H5992486, H5994838, H6004414, H6006510, H6018613, H6023827, H6036556, H6037354, H6042231, H6042232, H6047776, H6047777); 00763000529642 (0871070W, 0875987W, 0881338W, 0898398W, 0900793W, 0901214W, 0914604W, 0927306W, 1014874W, 1014876W, 1033196W, 1039840W, 1040657W, H5991291). 13. Model Number: SPS03143. GTIN: N/A; Lot Numbers: 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0077, 0078, 0079, 0080, 0081, 0082, 0083, 0084, 0085, 0086, 0087, 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0096, 0097, 0098, 0099, 0100, 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0220, 0221, 0222, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0245, 0246, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0257, 0258, 0259, 0260, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0276, 0277, 0278, 0279, 0280, 0281, 0282, 0283, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0299, 0300, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0309, 0310, 0311, 0312, 0313, 0314, 0315, 0316, 0317, 0318, 0319, 0320, 0321, 0322, 0323, 0324, 0325, 0326, 0327, 0328, 0329, 0330, 0331, 0332, 0333, 0334, 0335, 0336, 0337, 0338, 0339, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0347, 0348, 0349, 0350, 0351, 0352, 0353, 0354, 0355, 0356, 0357, 0358, 0359, 0360, 0361, 0362, 0363, 0364, 0365, 0366, 0367, 0368, 0369, 0370, 0371, 0372, 0373, 0374, 0375, 0376, 0377, 0378, 0379, 0380, 0381, 0382, 0383, 0384, 0385, 0386, 0387, 0388, 0389, 0390, 0391, 0392, 0393, 0394, 0395, 0397, 0398, 0399, 0400, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0408, 0409, 0410, 0412, 0413, 0414, 0415, 0416, 0417, 0418, 0419, 0420, 0421, 0422, 0423, 0424, 0425, 0426, 0427, 0428, 0429, 0430, 0431, 0432, 0433, 0434, 0435, 0437, 0438, 0439, 0440, 0441, 0442, 0443, 0444, 0445, 0446, 0447, 0448, 0449, 0450, 0452, 0453, 0454, 0456, 0457, 0458, 0459, 0460, 0461, 0462, 0463, 0464, 0466, 0467, 0468, 0469, 0470, 0471, 0472, 0473, 0474, 0475, 0476, 0477, 0478, 0479, 0480, 0481, 0482, 0483, 0484, 0485, 0486, 0487, 0488, 0489, 0490, 0491, 0493, 0495, 0496, 0497, 0498, 0499, 0500, 0501, 0502, 0503, 0504, 0505, 0506, 0507, 0508, 0510, 0511, 0512, 0513, 0514, 0515, 0516, 0517, 0518, 0519, 0520, 0521, 0522, 0523, 0524, 0525, 0526, 0527, 0528, 0529, 0530, 0531, 0532, 0533, 0534, 0535, 0536, 0538, 0539, 0543, 0545, 0546, 0549, 0550, 0551, 0552, 0553, 0554, 0555, 0556, 0557, 0558, 0559, 0560, 0561, 0562, 0563, 0564, 0565, 0566, 0567, 0568, 0569, 0570, 0571, 0572, 0573, 0574, 0575, 0576, 0577, 0578, 0579, 0580, 0581, 0582, 0583, 0585, 0586, 0587, 0588, 0589, 0590, 0591, 0592, 0593, 0594, 0595, 0596, 0597, 0598, 0599, 0600, 0601, 0602, 0603, 0604, 0605, 0606, 0607, 0608, 0609, 0610, 0611, 0612, 0613, 0614, 0615, 0616, 0617, 0618, 0619, 0620, 0621, 0622, 0623, 0624, 0625, 0626, 0627, 0629, 0630, 0631, 0632, 0633, 0634, 0636, 0637, 0638, 0639, 0640, 0641, 0642, 0643, 0644, 0645, 0646, 0647, 0648, 0649, 0650, 0651, 0652, 0653, 0654, 0655, 0656, 0657, 0658, 0659, 0660, 0661, 0662, 0663, 0664, 0665, 0666, 0667, 0668, 0669, 0670, 0671, 0672, 0673, 0674, 0676, 0677, 0678, 0679, 0680, 0681, 0682, 0683, 0684, 0685, 0686, 0687, 0688, 0689, 0690, 0691, 0692, 0693, 0694, 0695, 0696, 0697, 0698, 0699, 0700, 0702, 0703, 0704, 0705, 0706, 0707, 0708, 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720, 0721, 0722, 0723, 0724, 0725, 0726, 0727, 0728, 0729, 0730, 0731, 0732, 0733, 0734, 0735, 0736, 0737, 0738, 0739, 0740, 0741, 0742, 0743, 0744, 0745, 0746, 0747, 0748, 0750, 0751, 0752, 0753, 0754, 0756, 0758, 0759, 0760, 0761, 0762, 0763, 0764, 0765, 0766, 0767, 0768, 0769, 0770, 0772, 0774, 0776, 0779, 0781, 0782, 0785, 0786, 0787, 0788, 0789, 0791, 0793, 0794, 0797, 0798, 0800, 0801, 0802, 0803, 0804, 0805, 0806, 0807, 0808, 0809, 0810, 0811, 0814, 0817, 0818, 0819, 0820, 0824, 0825, 0830, 0831, 0832, 0834, 0836, 0838, 0840, 0842, 0843, 0844, 0846, 0847, 0848, 0850, 0852, 0853, 0856, 0858, 0860, 0864, 0868, 0869, 0870, 0880, 0882, 0884, 0886, 0888, 0890, 0900, 0919, 0924, 0929, 0934, 0937, 0946, 0949, 0509, 0540, 0541, 0542, 0544, 0628. 14. Model Number: SPS03144. GTIN: N/A; Lot Numbers: 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0077, 0078, 0079, 0080, 0081, 0082, 0083, 0085, 0086, 0087, 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0096, 0097, 0098, 0099, 0100, 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0220, 0221, 0222, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0245, 0246, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0258, 0259, 0260, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0271, 0273, 0274, 0275, 0276, 0277, 0278, 0279, 0280, 0281, 0282, 0283, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0299, 0300, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0309, 0310, 0311, 0312, 0313, 0314, 0315, 0316, 0317, 0318, 0319, 0320, 0322, 0323, 0324, 0325, 0326, 0327, 0328, 0329, 0330, 0331, 0332, 0333, 0334, 0335, 0336, 0337, 0339, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0348, 0349, 0350, 0351, 0352, 0353, 0354, 0355, 0356, 0357, 0358, 0360, 0361, 0362, 0363, 0364, 0365, 0366, 0367, 0368, 0369.0370, 0371, 0372, 0373, 0374, 0375, 0376, 0377, 0378, 0379, 0380, 0381, 0382, 0383, 0384, 0385, 0386, 0387, 0388, 0389, 0390, 0391, 0392, 0393, 0394, 0395, 0396, 0397, 0398, 0399, 0400, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0408, 0409, 0410, 0411, 0412, 0413, 0414, 0415, 0416, 0417, 0418, 0422, 0423, 0424, 0425, 0426, 0427, 0428, 0429, 0431, 0432, 0433, 0434, 0435, 0436, 0437, 0438, 0439, 0440, 0442, 0443, 0444, 0445, 0446, 0447, 0448, 0449, 0450, 0451, 0452, 0453, 0454, 0455, 0456, 0457, 0458, 0459, 0460, 0461, 0462, 0463, 0464, 0465, 0466, 0467, 0468, 0469, 0470, 0471, 0472, 0473, 0474, 0475, 0476, 0477, 0478, 0479, 0480, 0481, 0482, 0483, 0484, 0485, 0486, 0487, 0488, 0489, 0490, 0491, 0492, 0493, 0494, 0495, 0496, 0497, 0498, 0499, 0500, 0501, 0502, 0503, 0504, 0505, 0508, 0516, 0517, 0520, 0524, 0525, 0528, 0543, 0546, 0550. 15. Model Number: SPS04012. GTIN: N/A; Lot Numbers: 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064. 16. Model Number: SPS04013. GTIN: N/A; Lot Numbers: 0001, 0002, 0003, 0004, 0005, 0006, 0007, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075. 17. Model Number: SPSJEP40. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0220, 0221, 0222, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0245, 0246, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0260, 0261, 0262, 0263, 0264, 0280, 0281, 0282, 0283, 0284, 0285, 0286, 0287, 0288, 0290, 0291, 0292, 0294, 0295, 0296, 0298, 0299. 18. Model Number: SPSJEP4H. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144. 19. Model Number: SPSJEP4S. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0194, 0195, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0224, 0225. 20. Model Number: SPSJEP4T. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119. 21. Model Number: SPSJEPSH. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0194, 0195, 0196, 0197. 22. Model Number: SPSJEPSI. GTIN: N/A; Lot Numbers: 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0122, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0175, 0176, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0220, 0221, 0222, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0246, 0247, 0248, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0257, 0258, 0259, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0272, 0274, 0275, 0276, 0277, 0278, 0279, 0280, 0281, 0282, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0299, 0300, 0301, 0303, 0304, 0305, 0306, 0307, 0308, 0309, 0311, 0313, 0314, 0315, 0316, 0317, 0318, 0319, 0320, 0321, 0322, 0323, 0324, 0325, 0326, 0327, 0328, 0329, 0330, 0331, 0332, 0333, 0334, 0335, 0336, 0337, 0338, 0339, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0347, 0348, 0349, 0350, 0351, 0352, 0353, 0354, 0355, 0356, 0357, 0358, 0359, 0360, 0361, 0362, 0363, 0364, 0365, 0366, 0367, 0368, 0369, 0370, 0371, 0372, 0373, 0374, 0375, 0376, 0377, 0378, 0379, 0380, 0381, 0382, 0383, 0384, 0385, 0386, 0387, 0388, 0389, 0390, 0391, 0392, 0393, 0394, 0395, 0396, 0397, 0398, 0399, 0400.
Devices named in this recall
12 devices in the FDA device registry whose identifier appears in the recall's code information.
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
- Catalyft PL Expandable Interbody System 6068093Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall24 reports
- Catalyft PL Expandable Interbody System 6068096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall20 reports
- Catalyft PL Expandable Interbody System 6069073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall12 reports
- Catalyft PL Expandable Interbody System 6069093Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall12 reports
- Catalyft PL Expandable Interbody System 6069116Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall2 reports
- Catalyft PL Expandable Interbody System 6068113Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Catalyft PL Expandable Interbody System 6068116Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Catalyft PL Expandable Interbody System 6069113Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K210425 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Catalyft PL Expandable Interbody System 6061002Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar14 reports
- Catalyft PL Expandable Interbody System 6061000Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar3 reports
- Catalyft PL Expandable Interbody System 6061001Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 report
- Catalyft PL Expandable Interbody System NAV6061000Medtronic Sofamor Danek, Inc. · Orthopedic stereotaxic instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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