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Vantage recallZ-0024-2022 · Exactech, Inc. · initiated Aug 30, 2021

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

FDA root cause category: Process control

What the company is doing

Exactech notified distributors and sales representatives on about 08/30/2021 via letter titled "URGENT MEDICAL DEVICE RECALL." Actions included removing all Knee and Ankle UHMWPE products labeled with an 8-year shelf life and not packaged in EVOH/Nylon bags, in a phased approach over 12 months. Phase 1: immediately return all knee and ankle UHMWPE devices labeled with an 8-year shelf life that will be 5 years old or older by 08/31/2022 not packaged in EVOH/Nylon bags. Phase 2: between 05/31/2022 to 08/31/2022, returning all remaining knee and ankle UHMWPE devices labeled with an 8-year shelf life not packaged in EVOH/Nylon bags. A communication to healthcare professionals should follow. Instructions to recipients included to immediately identify and quarantine any affected product in inventory, notify customers down the line if further distributed, and complete and return the Recall Inventory Response Form to Exactech via email at [email protected]. Exactech expanded their recall and sent an updated notification to US agents and distributors on 02/07/2022. On about 02/08/2022, a letter to surgeons and hospitals was sent. The notifications indicated that all non-conforming devices were included in the recall, to cease use of those devices, and work with sales agents to return any inventory. The letters to surgeons and hospitals also advised physicians regarding follow up with implanted patients.

Recall details

Recall number
Z-0024-2022
Status
Open, Classified
Initiated by the company
Aug 30, 2021
Posted by the FDA
Oct 4, 2021
Recalling firm
Exactech, Inc.
Quantity
2,217 devices
Product code
HSN
FDA submissions
K152217
Distribution
Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SINGAPORE, SPAIN, SWITZERLAND, SYRIAN ARAB REPUBLIC, THAILAND, TUNISIA, TURKEY, VENEZUELA .

Product description

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Code information (models, lots, serial numbers)

Show the full code information (23k characters)

a. Item Number (Device Identifier; Serial number(s)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 6730688, 6730690, 6730696, 6730697, 6899729, 6899744, 6899751, Z068705, Z075029, Z075042); 350-21-03 (10885862276230; 4536738, 4536739, 4536740, 4536741, 4536742, 4536743, 4536745, 4536746, 4841023, 4841024, 4841025, 5184662, 5184663, 5184665, 5184666, 5184668, 5184669, 5184671, 5184672, 5184673, 5184674, 5184675, 5184678, 5184679, 5184680, 5221264, 5221265, 5221266, 5221267, 5221268, 5221269, 5221270, 5221272, 5221273, 5221274, 5221275, 5221276, 5940499, 5940500, 5940502, 5940507, 5940511, 5940516, 5940517, 5940518, 5940519, 5940520, 6039207, 6039208, 6039210, 6039212, 6039213, 6039214, 6039215, 6039218, 6039220, 6039221, 6039222, 6039223, 6039225, 6173447, 6173449, 6173450, 6173451, 6173452, 6173455, 6173456, 6173458, 6173459, 6173460, 6173462, 6173463, 6173464, 6173465, 6372717, 6372718, 6372719, 6372720, 6372721, 6372726, 6372727, 6372729, 6372730, 6372735, 6489128, 6489129, 6489131, 6489133, 6489134, 6489135, 6489136, 6489137, 6489145, 6489146, 6535721, 6535723, 6535724, 6535729, 6535730, 6535731, 6535732, 6535734, 6742242, 6742248, 6742249, 6742250, 6742251, 6742253, 6742255, 6742259, 6811600, 6811611, 6811612, 6900322, Z074962, Z074972, Z074984, Z075184); 350-21-04 (10885862276247; 4537204, 4537205, 4537206, 4537207, 4537212, 4750991, 5184539, 5184541, 5184543, 5184548, 5184550, 5184553, 5184554, 5184557, 5240718, 5240721, 5240727, 5240728, 5909332, 5909335, 5909337, 5909338, 5909344, 5909350, 5954808, 5954810, 5954815, 5954820, 6356463, 6356464, 6356466, 6356471, 6356472, 6356473, 6356477, 6489076, 6489081, 6489083, 6489093, 6758223, 6758226, 6758227, 6856945, 6856949, 6995782, Z068655); 350-21-11 (10885862276254; 4536710, 4536711, 4536714, 4536715, 4536716, 4536717, 4536718, 4704930, 4704938, 4704939, 4704940, 4704944, 4704945, 4704949, 4704951, 4704956, 4704957, 4787630, 4787631, 5184636, 5184639, 5184640, 5184643, 5231854, 5231855, 5231858, 5231860, 5969127, 5969128, 5969129, 5969132, 6356520, 6356523, 6489037, 6489045, 6489052); 350-21-12 (10885862276261; 4704789, 4771382, 4771383, 4771384, 4771387, 4771388, 5184684, 5184689, 5184690, 5184691, 5184697, 5184698, 5237420, 5237421, 5237422, 5237423, 5237424, 5237426, 5237430, 5237431, 5237432, 5939798, 5939801, 5939802, 5939803, 5939807, 5939810, 6356669, 6356670, 6356671, 6356672, 6356677, 6356680, 6356681, 6356683, 6356684, 6489360, 6489363, 6489365, 6489366, 6489369, 6489370, 6489372, 6598979, 6598980, 6598983, 6598985, 6843245, 6843247, 6843261, 6883796, Z058384, Z074986, Z074999); 350-21-13 (10885862276278; 4704790, 4771176, 4977232, 4977233, 4977235, 5181919, 5181921, 5181923, 5181926, 5181927, 5181931, 5181932, 5181934, 5222348, 5222349, 5222352, 5222355, 5222356, 5222357, 5222358, 5908535, 5908536, 5908537, 5908540, 5908541, 5908542, 5908544, 5908548, 5908549, 6061322, 6061327, 6323250, 6323261, 6395423, 6395424, 6395426, 6395428, 6488292, 6488297, 6488301, Z075109, Z075175); 350-21-14 (10885862276285; 4746009, 5184848, 5184851, 5184852, 5184853, 5184858, 5184860, 5184864, 5184865, 6143314, 6143323, 6143326, 6143329, 6143331, 6395394, 6395395, 6719894, Z076042); 350-21-21 (10885862276292; 4676330, 4676331, 4676332, 4676333, 4676334, 4676335, 4676336, 4676338, 4676345, 4676347, 4676351, 4676355, 5185107, 5185108, 5185110, 5185111, 5185113, 5185114, 5185117, 5185118, 5185119, 5245298, 5906409, 5906414, 5938419, 5938422, 5938424, 5938428, 6356532, 6356533, 6356537, 6356542, 6356549, 6486889, 6486890, 6486896, 6804245, 6900926); 350-21-22 (10885862276308; 4750965, 4771177, 5184866, 5184867, 5184870, 5184872, 5184873, 5184874, 5184878, 5184879, 5184880, 5184881, 5184883, 5876458, 5876461, 5876467, 6142807, 6142808, 6142811, 6142819, 6142825, 6411781, 6411784, 6428914, 6428917, 6428918, 6435219, 6435225, 6621519, 6621521, 6621524, 6621536, 6883664, 6883667, 6883671, 6959803, Z059779); 350-21-23 (10885862276315; 4771244, 4866126, 4866127, 4866129, 5172559, 5172560, 5172565, 5172566, 5172567, 5172569, 5172570, 5172572, 5172574, 5172577, 5172580, 5172581, 5172582, 5172583, 5172584, 5172588, 5172589, 5989847, 5989848, 5989849, 5989850, 5989853, 5989859, 5989861, 6408952, 6408954, 6408958, 6408959, 6408960, 6487891, 6487893, 6487895, 6487896, 6487897, 6487900, 6487902, 6487908, 6487909, 6644822, 6644825, 6644826, 6644831, 6644834, 6644835, 6644838, Z058458, Z058462, Z060686); 350-21-24 (10885862276322; 4536720, 4536721, 4536723, 4536724, 5185120, 5185127, 5185129, 5185132, 5185133, 5185134, 5185135, 5245294, 5245296, 5882353, 5882355, 5882358, 5882364, 5882365, 6142592, 6142601, 6142602, 6142605, 6142607, 6142608, 6396151, 6396156, 6851740, Z058435); 350-21-41 (10885862293213; 5181205, 5181206, 5181209, 5181210, 5181211, 5181212, 5181214, 5181215, 5181217, 5181218, 5181219, 5181222, 5954729, 5954730, 5954736, 5954745, 6409727, 6747749, 6747752, 6897935); 350-21-42 (10885862293220; 5184830, 5184831, 5184833, 5184837, 5184838, 5184839, 5184840, 5184844, 5184845, 5201342, 5201345, 5201349, 5909253, 5940479, 5940481, 5940482, 5940484, 5940487, 5940493, 5940495, 6143274, 6143276, 6143277, 6143282, 6143285, 6143286, 6143289, 6143292, 6396172, 6540417, 6540421, 6911569, Z059753); 350-21-43 (10885862293237; 5102165, 5102166, 5102171, 5102173, 5102174, 5102178, 5102179, 5102180, 5102183, 5230186, 5230190, 5230192, 5230196, 5230197, 5230199, 5230200, 5230203, 5912834, 5912837, 5912838, 5912840, 5912844, 5912846, 5912848, 6015723, 6015725, 6015728, 6395893, 6395900, 6571764, 6571775, 6860987, 6913035, Z077359); 350-21-44 (10885862293244; 5181165, 5181177, 5181178, 5967776, 5967781, 6325734, 6398023, 6424762, 6709425); 350-21-61 (10885862293374; 5185137, 5185147, 5909303); 350-21-62 (10885862293381; 6143359, 6143360, 6143368, 6143370, Z060582); 350-21-63 (10885862293398; 4733268, 5185157, 6487566); 350-21-64 (10885862293404; 5185168, 6143340, 6143348, 6488098); 350-22-01 (10885862276339; 4681920, 4681922, 4681923, 4681925, 4681927, 4681928, 4681930, 4681931, 4681932, 4681933, 4681934, 4681935, 4681937, 4681938, 4681940, 4681943, 4681945, 4681946, 4681948, 4681949, 5139951, 5139952, 5139953, 5139955, 5139956, 5139962, 5139963, 5139968, 5139970, 5139971, 5876391, 5876392, 5876393, 5876396, 5876398, 5876399, 5876403, 5876407, 5876412, 6127984, 6127985, 6127987, 6127993, 6127995, 6127997, 6128000, 6128003, 6395402, 6395406, 6395407, 6395410, 6395417, 6487092, 6487093, 6487094, 6487095, 6487097, 6487100, 6487102, 6487103, 6487106, 6487107, 6487108, 6487110, 6720137, 6720139, 6720142, 6720145, 6720146, 6720150, 6720152, 6720153, 6907877, 6907886, 6907887, 6907888, 6907892, 6907896, 6907899, 6907901, 6911587, 6911594, Z073322, Z073329); 350-22-02 (10885862276346, 4771234, 4771235, 4771236, 4771237, 4771238, 4771239, 4771240, 5181224, 5181225, 5181228, 5181229, 5181234, 5181235, 5181236, 5181237, 5181238, 5181239, 5181240, 5181241, 5181242, 5181244, 5245289, 5245290, 5245291, 5245292, 5245293, 5985462, 5985463, 5985464, 5985466, 5985468, 5985470, 5985471, 5985472, 5985473, 5985474, 5985475, 5985476, 5985477, 5985478, 5985480, 5985481, 6048026, 6048027, 6048028, 6048030, 6048031, 6067781, 6067782, 6067783, 6067785, 6067786, 6067787, 6067788, 6067790, 6067792, 6259896, 6259897, 6308445, 6308446, 6308447, 6308448, 6308451, 6308452, 6308454, 6308458, 6411977, 6411978, 6411979, 6411980, 6411981, 6411983, 6411984, 6411985, 6411989, 6434808, 6434811, 6434812, 6434813, 6434814, 6434816, 6434817, 6434818, 6434820, 6434821, 6434822, 6434823, 6434824, 6532890, 6532891, 6532895, 6532898, 6532899, 6532900, 6532902, 6532903, 6532904, 6532907, 6535639, 6535641, 6535643, 6535644, 6535645, 6535646, 6535649, 6535650, 6535651, 6535654, 6535657, 6758072, 6758073, 6758074, 6899905, 6899911, 6899914, 6899919, Z071104, Z071116, Z071136, Z076051); 350-22-03 (10885862276353; 4884296, 4884297, 4884298, 4884299, 5185183, 5185184, 5185187, 5185189, 5185190, 5185191, 5185192, 5185194, 5185195, 5185196, 5256071, 5256072, 5256073, 5256074, 5256075, 5256077, 5256078, 5256079, 5256080, 5938438, 5938439, 5938440, 5938441, 5938442, 5938447, 5938448, 5938451, 5938452, 5938453, 5938454, 5938456, 5938457, 5988014, 5988015, 5988016, 5988018, 5988019, 5988020, 5988022, 5988023, 5988025, 5988026, 5988027, 5988029, 5988030, 6252633, 6252634, 6252636, 6252638, 6252640, 6252641, 6285206, 6285207, 6285208, 6285210, 6285211, 6285212, 6285213, 6285215, 6340621, 6340630, 6340631, 6340632, 6340635, 6395438, 6395439, 6395440, 6395441, 6395444, 6395446, 6395451, 6395456, 6395457, 6482649, 6482650, 6482656, 6482662, 6482664, 6482665, 6509210, 6509214, 6509215, 6509216, 6509218, 6509219, 6509220, 6509223, 6509224, 6509227, 6683471, 6683474, 6683475, 6683477, 6683482, 6683485, 6683488, 6683492, 6718699, 6718707, 6718715, 6718716, 6852366, 6852367, 6852368, 6852375, 6852377, 6852379, 6853420, 6853427, 7010354, Z072696, Z073295); 350-22-04 (10885862276360; 5181310, 5181313, 5181314, 5181315, 5181317, 5181323, 5181327, 5262727, 5262729, 5262730, 5262731, 5262733, 5262735, 5262736, 5262737, 5907662, 5907666, 5907670, 5907671, 5907672, 5907673, 5907674, 5907676, 5967477, 5967482, 5967487, 5967488, 5967489, 5967491, 5967493, 5967494, 5967495, 6337400, 6337402, 6337406, 6337407, 6482499, 6502574, 6502576, 6502580, 6502586, 6502589, 6846082, 6846088, Z058442, Z058443, Z075357); 350-22-11 (10885862276377; 4703168, 4703171, 4703174, 4703177, 4703178, 4703179, 4703180, 4703183, 4703184, 4703187, 4703188, 4703190, 4703191, 4703192, 4703193, 4703194, 4703195, 4703196, 4703197, 4857844, 4857845, 4857846, 4857847, 5181328, 5181331, 5181336, 5181337, 5181338, 5181339, 5181341, 5181343, 5181345, 5954756, 5954758, 5954759, 5954761, 5954765, 6137105, 6137106, 6137115, 6137119, 6137121, 6372459, 6372468, 6372471, 6372474, 6372475, 6487131, 6487137, 6898086, Z075079); 350-22-12 (10885862276384; 4704788, 4771243, 5181347, 5181348, 5181349, 5181351, 5181352, 5181353, 5181354, 5181355, 5181356, 5181359, 5181360, 5181363, 5181364, 5193990, 5193991, 5193993, 5193995, 5193996, 5193997, 5193998, 5193999, 5194001, 5194002, 5194003, 5194004, 5882202, 5882208, 5882209, 5882210, 5882211, 5882212, 5882214, 5882215, 5882216, 5882218, 5882219, 5882282, 5882283, 5882284, 5882285, 5882286, 5882292, 5882295, 6356685, 6356691, 6356694, 6356695, 6356703, 6428946, 6489020, 6489021, 6489025, 6489026, 6489029, 6489031, 6502624, 6502629, 6502633, 6502634, 6683224, 6683231, 6898077, 6970223, 6970236, Z075900); 350-22-13 (10885862276391; 4771241, 4771242, 5120877, 5120882, 5120885, 5120886, 5120887, 5120889, 5204239, 5204240, 5204242, 5204244, 5204245, 5204247, 5204248, 5204250, 5204251, 5204252, 5939735, 5939741, 5939742, 5939744, 5939745, 5939746, 5939748, 5939749, 5939750, 5939751, 5939752, 5939753, 5939754, 6136641, 6136646, 6136649, 6136650, 6136651, 6428891, 6428893, 6489094, 6489097, 6489109, 6489124, 6489125, 6856921, 6856930, 6856931, Z058368, Z058370, Z074916); 350-22-14 (10885862276407; 5181368, 5181373, 5181374, 5181376, 5181380, 5181381, 5181383, 5906479, 5967548, 5967552, 5967553, 5967560, 5967564, 5967567, 6174579, 6174584, 6174589, 6569281, 6569289); 350-22-21 (10885862276414; 4703140, 4703141, 4703142, 4703143, 4703144, 4703147, 4703148, 4703149, 4703152, 4703154, 4703155, 4703156, 4703158, 4703160, 4703162, 4703163, 4703165, 4703167, 5185215, 5185216, 5185219, 5185221, 5185223, 5185225, 5185228, 5214261, 5214264, 5214265, 5939780, 5939788, 5939789, 6259901, 6395459, 6395470, 6591152, 6591161, 6591163); 350-22-22 (10885862276421; 4748658, 4771389, 5120893, 5120894, 5120895, 5120897, 5120898, 5120899, 5120900, 5120901, 5120902, 5120906, 5120907, 5120909, 5120912, 5120913, 5120914, 5120915, 5241242, 5241243, 5241244, 5241245, 5241246, 5241247, 5241248, 5241249, 5241250, 5241251, 5241252, 6015770, 6015777, 6015788, 6395920, 6487170, 6487175, 6487177, 6487179, 6487180, 6487181, 6742061, 6742065, 6742069, 6911514, Z075188, Z075281); 350-22-23 (10885862276438; 4771390, 4771392, 4771393, 4771394, 5181291, 5181294, 5181295, 5181296, 5181297, 5181299, 5181300, 5181301, 5181302, 5181303, 5181304, 5181305, 5181308, 5880510, 5880511, 5880514, 5880525, 5938089, 5938090, 5938091, 5938093, 5938096, 5938097, 5938099, 5938103, 5938105, 5938106, 5938107, 6395828, 6395831, 6395833, 6395837, 6395843, 6411724, 6411725, 6411726, 6411729, 6411730, 6411731, 6411735, 6411738, 6411741, 6506227, 6506228, 6506231, 6506234, 6506235, 6506239, 6506242, 6506243, 6734441, 6734442, 6734444, 6734447, 6734454, 6734455, 6870162, 6870183, 6870188, Z075253); 350-22-24 (10885862276445; 5181451, 5181453, 5181455, 5181458, 5181459, 5181464, 5232860, 5232861, 5232864, 5232867, 5232869, 5232870, 5232871, 5232874, 5232876, 5232877, 5907747, 5907751, 5939721, 5939727, 5939732, 6395493, 6395506, 6487126, 6487130, 6822884, 6822896, Z060416, Z069324); 350-22-41 (10885862293251; 5187946, 5187954, 5187956, 5907658, 5954768, 5954774, 5954779, 6396518, 6396521, 6489006); 350-22-42 (10885862293268; 5185783, 5185787, 5185788, 5185789, 5185790, 5185793, 5185794, 5185795, 5185799, 5185801, 5201264, 5201265, 5201266, 5201272, 5201273, 5201275, 5201276, 5201278, 5938401, 5938402, 5938404, 5938409, 5938411, 5938416, 6391264, 6483678, 6483684, 6483687, 6520721, 6520724, 6520725, 6520732, 6520733, 6520737, 6738668, 6738674, 6898015, 6898023, Z070796, Z070802); 350-22-43 (10885862293275; 5122629, 5122632, 5122635, 5122637, 5122638, 5122643, 5122645, 5122646, 5122648, 5260636, 5260638, 5260642, 5260643, 5260645, 5883315, 5883316, 5883324, 5940026, 5940027, 5940029, 5940033, 5940037, 5940038, 5940039, 5940041, 5940042, 6273558, 6273559, 6273562, 6273568, 6273570, 6412019, 6579440, 6579442, 6579443, 6579448, 6886404, Z060757); 350-22-44 (10885862293282; 5185203, 5185206, 5185209, 5967508, 5967510, 6417987, 6683339, 6737449); 350-22-62 (10885862293428; 5181465, 5181473, 5181484, 5948972, 5948990); 350-22-63 (10885862293435; 5181395, 5906439, 5906440, 6409703, 6409711, 6409712, Z077335); 350-22-64 (10885862293442; 5181406, 5181407, 5181414, 5181421, 5975072, 5975080); b. Item Number (Device Identifier; Serial number(s)): 350-41-01 (10885862276452; 4851797, 4851798, 4851799, 4851800, 4964108, 4986270, 5194348, 5194350, 5194353, 5194356, 5194357, 5194358, 6409670, 6506001, 6506009, 6857644, 6857646, 6857652); 350-41-02 (10885862276469; 4850102, 4850103, 4850104, 4850105, 4963948, 4963951, 5194275, 5194276, 5194277, 5194279, 5194280, 5194281, 5194282, 5194283, 5194285, 5194286, 5194287, 5194288, 5194289, 5194290, 5194291, 5194292, 5865068, 5865072, 5865073, 5865076, 5865081, 5865086, 5865087, 5865089, 6330721, 6330728, 6330732, 6507180, 6507186, 6507198, 6592234, 6592235); 350-41-03 (10885862276476; 4851814, 4851816, 4963859, 4963860, 4963862, 5181425, 5181426, 5181428, 5181430, 5181432, 5181433, 5181434, 5181435, 5181436, 5181438, 5181440, 5181441, 5181443, 5181444, 6138428, 6409639, 6409640, 6409644, 6409647, 6409650, 6409651, 6409652, 6409658, 6535259, 6535265, 6535268, 6900013); 350-41-04 (10885862276483; 4851782, 4851783, 4851784, 4913716, 5193807, 5193811, 5193813, 5193819, 6143103, 6143110, 6506247, 6506251, 6506260, 6506262, 6506263); 350-41-05 (10885862302038; 5192099); 350-41-11 (10885862276490; 4851670, 4851671, 4851672, 4963858, 5194262, 5194265, 5194268, 5194274, 6506369, 6506380); 350-41-12 (10885862276506; 4850106, 4850107, 4850108, 4850109, 4913690, 4913691, 4913693, 5194293, 5194294, 5194297, 5194304, 5194307, 6505962, 6505963, 6505968, 6566991, 6566994, 6566999, 6567000); 350-41-13 (10885862276513; 4850078, 4850079, 4850080, 4850081, 4963842, 5194329, 5194331, 5194333, 5194334, 5194336, 5194338, 5194339, 5194342, 5194345, 6141325, 6141326, 6141329, 6439029, 6439031, 6439041, 6825226); 350-41-14 (10885862276520; 4851603, 4913723, 4913724, 4913725, 5193794, 5193795, 5193798, 5193806, 6143269, 6776618, 6776626); 350-41-15 (10885862302045; 5194254); 350-41-21 (10885862276537; 4850098, 4850099, 4850100, 4963849, 4963850, 4963852, 5205336, 5205342, 5205346, 5205347, 6506333, 6506347); 350-41-22 (10885862276544; 4851637, 4851638, 4851639, 4851640, 4930455, 4930456, 4930458, 4930460, 5250981, 5250983, 5250985, 5250986, 5250987, 5250988, 6143140, 6507141, 6922888, Z081039); 350-41-23 (10885862276551; 4850110, 4850111, 4850112, 4913660, 4913661, 4913662, 4913663, 5194236, 5194237, 5194239, 5194240, 5194246, 5194247, 5194248, 5194250, 5194251, 5194252, 6141292, 6141293, 6466622, 6504528, 6504529, 6775088, 6775098, 6775102); 350-41-24 (10885862276568; 4850094, 4850095, 4850096, 4850097, 4963769, 4963772, 5184563, 5184566, 5184568, 5184571, 5184576, 6141203, 6505950, 6505958); 350-41-25 (10885862302052; 5194176, 5194177); 350-41-41 (10885862293534; 4851727, 4963764, 4963765, 5194226, 5194231); 350-41-42 (10885862293541; 4850090, 4850091, 4850092, 4850093, 4963759); 350-41-43 (10885862293558; 4851761, 4851763, 4963777, 4963778, 4963780, 5194201, 5194203, 5194206, 5194212, 5194215, 5194216, 6143085, 6506501); 350-41-44 (10885862293565; 4851693, 4963661, 4963662, 5193851, 5193852, 6139778, 6139786); 350-41-45 (10885862302076; 5194180); 350-41-61 (10885862293695; 4851597, 4851598); 350-41-62 (10885862293701; 4851588, 4963649, 5194100); 350-41-63 (10885862293718; 4851593, 4851594); 350-41-64 (10885862293725; 4851599, 4851600, 5194096); 350-41-65 (10885862302090, 5194116, 5194118); 350-42-01 (10885862276575; 4851765, 4851766, 4851767, 4851768, 4962062, 4962065, 4962067, 5181941, 5181942, 5181945, 5181948, 5181949, 5181951, 5181955, 5181956, 5181957, 6504541, 6504544, 6504545, 6504547, 6504548, 6504550, 6813572, 6813577, 7009630); 350-42-02 (10885862276582; 4847130, 4847131, 4847132, 4962961, 4962964, 4962965, 5194138, 5194139, 5194140, 5194141, 5194143, 5194145, 5194147, 5194149, 5194150, 5194152, 5194153, 5194155, 5910497, 5910507, 6442342, 6442348, 6442351, 6506023, 6506024, 6506029, 7011500); 350-42-03 (10885862276599; 4847207, 4847208, 4847209, 4847210, 4863354, 4863355, 4863356, 4863357, 4863358, 4863359, 4863360, 5229805, 5229806, 5229807, 5229809, 5229812, 5229813, 5229815, 5229817, 5229819, 5229820, 5229821, 5229822, 6070811, 6070812, 6356277, 6356281, 6356282, 6356284, 6356286, 6356288, 6356289, 6356292, 6356293, 6356295, 6570281, 6570284, 6570291, 6570292, 6570297, 6862327, 6862328, 6862329, 6862332, 6862333); 350-42-04 (10885862276605; 4847172, 4847173, 4847174, 4914356, 4914359, 4959353, 4959356, 4959357, 5245932, 5245934, 5245935, 5245936, 5245938, 5245939, 5245942, 5245944, 6095443, 6095450, 6095453, 6095455, 6505375, 6505376, 6505383, 6505384, 6505385, 6505390, 6505392); 350-42-05 (10885862302106; 5192871); 350-42-11 (10885862276612; 4851829, 4851830, 4851831, 4851832, 4962030, 5192065, 5192067, 5192070, 5192071, 5192075, 5192077, 6143134, 6506128, 6506130, 6981225); 350-42-12 (10885862276629; 4847136, 4847137, 4914322, 4914323, 4914325, 4959360, 4959361, 4959363, 4959364, 5234643, 5234651, 5234652, 5234654, 6138480, 6138483, 6138489, 6505702, 6505703, 6505708, 6505709, 6505711, 6861040, 6861055); 350-42-13 (10885862276636; 4851580, 4851581, 4851582, 4959342, 4959346, 5181960, 5181961, 5181963, 5181964, 5181965, 5181966, 5181967, 5181970, 5181971, 5181972, 5181974, 5181975, 5181976, 5181977, 6143249, 6143253, 6456685, 6456692, 6456695, 6456703, 6591960, 6591961, 6591962, 6982233, 6982235, 6982236, Z081206, Z081219, Z081222); 350-42-14 (10885862276643; 4851584, 4851586, 4914362, 4914363, 4914364, 4914365, 4959348, 4959350, 5247865, 5247867, 5247870, 5247876, 6095825, 6095826, 6095835, 6458504, 6504558, 6504563, 6795422, 6795424); 350-42-15 (10885862302113; 5192877, 5192879); 350-42-21 (10885862276650; 4851469, 4851470, 4851471, 4851472, 4959335, 5192816, 5192820, 5192822, 6143099, 6143102, 6505394, 6505399, 6505404, 6505407, 6505409, 6505410); 350-42-22 (10885862276667; 4851477, 4851478, 4851479, 4851480, 4963995, 5192850, 5192851, 5192852, 5192853, 5192854, 5192855, 5192856, 5192857, 5192859, 5192862, 5192864, 5192865, 5192866, 6013085, 6013087, 6013088, 6504632, 6504637, 6504640, 6504641, 6900864); 350-42-23 (10885862276674; 4850086, 4850087, 4850088, 4850089, 4915608, 4915609, 4915610, 4959366, 4959367, 4959368, 4959369, 4959370, 5247851, 5247852, 5247853, 5247855, 5247857, 5247861, 6140620, 6140624, 6140626, 6505022, 6505024, 6505035, 6505037); 350-42-24 (10885862276681; 4851474, 4851476, 4964102, 4964105, 4964106, 5192835, 5192837, 5192841, 5192842, 6505078, 6505084, 6505086, 6505090, 6505093, 6505094, 6505095); 350-42-25 (10885862302120; 5192873); 350-42-41 (10885862293572; 4851484, 4964051, 4964054, 4964055, 6140502, 6505414, 6505426, 6505429); 350-42-42 (10885862293589; 4851486, 4851487, 4851488, 4964095, 4964096, 4964097, 5192764, 5192765, 5192771, 5192777, 6143120, 6566946, 6566948); 350-42-43 (10885862293596; 4851501, 4851502, 4851503, 4851504, 5192747); 350-42-44 (10885862293602; 4850481, 4850482, 4850484, 4964061, 5192734); 350-42-45 (10885862302144; 5192492); 350-42-61 (10885862293732; 4850491, 4964127, 4964130); 350-42-62 (10885862293749; 4850477, 4850479, 5193940); 350-42-63 (10885862293756; 4850485, 4850486, 4850488, 5194360, 6138511); 350-42-64 (10885862293763; 4964131, 4964133, 5194389, 5194394); 350-42-65 (10885862302168, 5192508);

Devices named in this recall

39 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

21 devices cleared under K152217 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88570).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page