Skip to content

NexGen recallZ-1608-2024 · Zimmer, Inc. · initiated Mar 28, 2024

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 Zimmer, 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

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

FDA root cause category: Process change control

What the company is doing

Consignees were sent an URGENT MEDICAL DEVICE RECALL notification dated 3/28/24. Distributors are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory, return all affected product from the respective distributorship and affected hospitals to Zimmer by submitting an Inventory Return Certification Form to [email protected] (international returns are to be coordinated by emailing [email protected]), and retain a copy of the Inventory Return Certification and product returns forms. Risk Managers are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory with the assistance of a Zimmer Biomet sales representative, the Zimmer Biomet sales representative will remove affected devices from consignee facilities, return the provided Certificate of Acknowledgement to [email protected], and retain a copy of the acknowledgement form for your records. Surgeons are to review the provided notification, complete the provided Certificate of Acknowledgement to [email protected], retain a copy of the acknowledgement form for your records; there is no specific patient monitoring instructions related to this recall. Consignees with any questions are to contact Customer Service at 574-371-3071 from Monday through Friday between the hours of 8:00 am and 5:00 pm EST.

Recall details

Recall number
Z-1608-2024
Status
Open, Classified
Initiated by the company
Mar 28, 2024
Posted by the FDA
Apr 22, 2024
Recalling firm
Zimmer, Inc.
Quantity
5,546 units
Product code
JWH
FDA submissions
K031061
Distribution
Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.

Product description

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

Code information (models, lots, serial numbers)

Show the full code information (15k characters)

Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, (01)00889024207806(17)281130(10)64226007, (01)00889024207806(17)281130(10)64226008, (01)00889024207820(17)281130(10)64220651, (01)00889024207790(17)281130(10)64226001, (01)00889024207806(17)281130(10)64226006, (01)00889024207806(17)281130(10)64202119, (01)00889024207790(17)281130(10)64226002, (01)00889024207806(17)281130(10)64202118, (01)00889024207790(17)281231(10)64254389, (01)00889024207806(17)281231(10)64254390, (01)00889024207806(17)281231(10)64226077, (01)00889024207806(17)281231(10)64226078, (01)00889024207806(17)281231(10)64226009, (01)00889024207790(17)281231(10)64226076, (01)00889024207790(17)281231(10)64254387, (01)00889024207790(17)281231(10)64254388, (01)00889024207806(17)281231(10)64261032, (01)00889024207806(17)281231(10)64226129, (01)00889024207820(17)281231(10)64242244, (01)00889024207790(17)281231(10)64254386, (01)00889024207790(17)281231(10)64226076R, (01)00889024207790(17)281231(10)64254386R, (01)00889024207790(17)281231(10)64254387R, (01)00889024207790(17)290131(10)64261030, (01)00889024207790(17)290131(10)64275592, (01)00889024207806(17)290131(10)64275434, (01)00889024207806(17)290131(10)64261033, (01)00889024207806(17)290131(10)64261035, (01)00889024207790(17)290131(10)64261031, (01)00889024207806(17)290131(10)64275593, (01)00889024207790(17)290131(10)64261029, (01)00889024207790(17)290131(10)64275538, (01)00889024207806(17)290131(10)64275540, (01)00889024207820(17)290131(10)64261037, (01)00889024207813(17)290131(10)64261036, (01)00889024207790(17)290131(10)64275537, (01)00889024207806(17)290131(10)64275435, (01)00889024207790(17)290131(10)64275433, (01)00889024207806(17)290131(10)64275541, (01)00889024207813(17)290131(10)64261036R, (01)00889024207790(17)290131(10)64261031R, (01)00889024207806(17)290131(10)64275593R, (01)00889024207790(17)290228(10)64294621, (01)00889024207820(17)290228(10)64306997, (01)00889024207790(17)290228(10)64302414, (01)00889024207790(17)290228(10)64306991, (01)00889024207806(17)290228(10)64302416, (01)00889024207806(17)290228(10)64306994, (01)00889024207806(17)290228(10)64302415, (01)00889024207790(17)290228(10)64275591, (01)00889024207790(17)290228(10)64275432, (01)00889024207806(17)290228(10)64306994R, (01)00889024207806(17)290228(10)64302415R, (01)00889024207790(17)290228(10)64302414R, (01)00889024207806(17)290331(10)64346982, (01)00889024207806(17)290331(10)64334419, (01)00889024207806(17)290331(10)64306995, (01)00889024207806(17)290331(10)64261034, (01)00889024207790(17)290331(10)64306992, (01)00889024207790(17)290331(10)64306993, (01)00889024207813(17)290331(10)64306996, (01)00889024207806(17)290331(10)64334418, (01)00889024207806(17)290331(10)64334420, (01)00889024207790(17)290331(10)64306992R, (01)00889024207790(17)290331(10)64306993R, (01)00889024207813(17)290331(10)64306996R, (01)00889024207790(17)290430(10)64346981, (01)00889024207790(17)290430(10)64367312, (01)00889024207806(17)290430(10)64367404, (01)00889024207806(17)290430(10)64346996, (01)00889024207806(17)290430(10)64367314, (01)00889024207790(17)290430(10)64334415, (01)00889024207790(17)290430(10)64334416, (01)00889024207790(17)290430(10)64346995, (01)00889024207790(17)290430(10)64367311, (01)00889024207790(17)290430(10)64367311R, (01)00889024207790(17)290531(10)64367403, (01)00889024207790(17)290531(10)64367313, (01)00889024207806(17)290531(10)64408081, (01)00889024207806(17)290531(10)64367316, (01)00889024207806(17)290630(10)64367318, (01)00889024207813(17)290630(10)64400527, (01)00889024207820(17)290630(10)64406831, (01)00889024207806(17)290630(10)64406829, (01)00889024207790(17)290630(10)64400526, (01)00889024207790(17)290630(10)64406828, (01)00889024207806(17)290630(10)64406830, (01)00889024207790(17)290630(10)64406827, (01)00889024207790(17)290731(10)64442403, (01)00889024207790(17)290731(10)64414262, (01)00889024207790(17)290831(10)64442404, (01)00889024207790(17)290831(10)64442405, (01)00889024207806(17)290831(10)64442407, (01)00889024207790(17)290831(10)64442406, (01)00889024207806(17)290831(10)64442407R, (01)00889024207806(17)290930(10)64442408, (01)00889024207790(17)290930(10)64480241, (01)00889024207820(17)290930(10)64500130, (01)00889024207790(17)290930(10)77009443, (01)00889024207806(17)291031(10)64480265, (01)00889024207806(17)291031(10)64540911, (01)00889024207806(17)291031(10)64480242, (01)00889024207806(17)291031(10)64480243, (01)00889024207790(17)291031(10)64480264, (01)00889024207813(17)291031(10)64480244, (01)00889024207790(17)291130(10)64575335, (01)00889024207790(17)291130(10)64575349, (01)00889024207806(17)291130(10)64575359, (01)00889024207806(17)291130(10)64575350, (01)00889024207806(17)291130(10)64540917, (01)00889024207790(17)291130(10)64575340, (01)00889024207790(17)291231(10)64579745, (01)00889024207806(17)291231(10)64579720, (01)00889024207790(17)300131(10)64597631, (01)00889024207806(17)300131(10)64597589, (01)00889024207813(17)300131(10)64597633, (01)00889024207790(17)300131(10)64597617, (01)00889024207806(17)300131(10)64597632, (01)00889024207806(17)300228(10)64675420, (01)00889024207806(17)300228(10)64597618, (01)00889024207790(17)300228(10)64675429, (01)00889024207806(17)300228(10)64675430, (01)00889024207806(17)300331(10)64699333, (01)00889024207790(17)300331(10)64675440, (01)00889024207806(17)300430(10)64675436, (01)00889024207813(17)300531(10)64699359, (01)00889024207790(17)300531(10)64699328, (01)00889024207790(17)300531(10)64699369, (01)00889024207806(17)300531(10)64699370, (01)00889024207806(17)300531(10)64699352, (01)00889024207806(17)300531(10)64675448, (01)00889024207806(17)300630(10)64699392, (01)00889024207806(17)300630(10)64699383, (01)00889024207790(17)300630(10)64699391, (01)00889024207790(17)300718(10)11024790, (01)00889024207790(17)300731(10)64699406, (01)00889024207806(17)300930(10)64808827, (01)00889024207806(17)301003(10)64808820, (01)00889024207806(17)301014(10)64825317, (01)00889024207790(17)301017(10)64808824, (01)00889024207790(17)301018(10)64808826, (01)00889024207806(17)301020(10)64808835, (01)00889024207806(17)301020(10)64827305, (01)00889024207806(17)301025(10)64827304, (01)00889024207806(17)301026(10)64808843, (01)00889024207806(17)301030(10)64808850, (01)00889024207790(17)301104(10)64808849, (01)00889024207790(17)301104(10)64808858, (01)00889024207790(17)301107(10)64808839, (01)00889024207806(17)301115(10)64808866, (01)00889024207790(17)301130(10)64808878, (01)00889024207790(17)301130(10)64808873, (01)00889024207806(17)301205(10)64808879, (01)00889024207806(17)301207(10)64808887, (01)00889024207790(17)301214(10)64808893, (01)00889024207806(17)310111(10)64928262, (01)00889024207806(17)310112(10)64928265, (01)00889024207790(17)310113(10)64928264, (01)00889024207806(17)310116(10)64827306, (01)00889024207806(17)310123(10)64928273, (01)00889024207790(17)310124(10)64928272, (01)00889024207806(17)310127(10)64928279, (01)00889024207790(17)310206(10)64928281, (01)00889024207806(17)310210(10)64928290, (01)00889024207790(17)310214(10)64928292, (01)00889024207806(17)310221(10)64928301, (01)00889024207790(17)310307(10)64928310, (01)00889024207806(17)310308(10)64928316, (01)00889024207813(17)310308(10)64928312, (01)00889024207790(17)310316(10)64928325, (01)00889024207806(17)310317(10)64928326, (01)00889024207806(17)310324(10)64928337, (01)00889024207790(17)310327(10)64928336, (01)00889024207806(17)310331(10)64928345, (01)00889024207806(17)310407(10)65038141, (01)00889024207790(17)310407(10)65038133, (01)00889024207790(17)310407(10)65038134, (01)00889024207790(17)310407(10)65038135, (01)00889024207806(17)310413(10)65038145, (01)00889024207790(17)310414(10)65038144, (01)00889024207790(17)310418(10)65038149, (01)00889024207790(17)310420(10)65038142, (01)00889024207806(17)310420(10)65038150, (01)00889024207790(17)310426(10)65038154, (01)00889024207790(17)310428(10)65038158, (01)00889024207790(17)310428(10)65038140, (01)00889024207806(17)310428(10)65038159, (01)00889024207790(17)310501(10)65038162, (01)00889024207790(17)310504(10)65038168, (01)00889024207806(17)310508(10)65038169, (01)00889024207790(17)310510(10)65038170, (01)00889024207806(17)310510(10)65038171, (01)00889024207790(17)310519(10)65038178, (01)00889024207790(17)310522(10)65038182, (01)00889024207806(17)310522(10)65038179, (01)00889024207790(17)310525(10)65038137, (01)00889024207790(17)310530(10)65038138, (01)00889024207790(17)310530(10)65038139, (01)00889024207790(17)310531(10)65038136, (01)00889024207806(17)310609(10)65081582, (01)00889024207806(17)310621(10)65081588, (01)00889024207806(17)310623(10)65081597, (01)00889024207806(17)310713(10)65117638, (01)00889024207806(17)310720(10)65117642, (01)00889024207806(17)310804(10)65117654, (01)00889024207806(17)311127(10)65203277, (01)00889024207806(17)311127(10)65203273, (01)00889024207806(17)311128(10)65117670, (01)00889024207806(17)311128(10)65117659, (01)00889024207806(17)311128(10)65203270, (01)00889024207806(17)311129(10)65203271, (01)00889024207806(17)311213(10)65203283, (01)00889024207806(17)311214(10)65203279, (01)00889024207790(17)320102(10)65117658, (01)00889024207790(17)320105(10)65117669, (01)00889024207790(17)320119(10)65117682, (01)00889024207813(17)320305(10)65346422, (01)00889024207806(17)320319(10)65356469, (01)00889024207806(17)320329(10)65356467, (01)00889024207820(17)320403(10)65384861, (01)00889024207790(17)320417(10)65397002, (01)00889024207806(17)320430(10)65403274, (01)00889024207806(17)320504(10)65410849, (01)00889024207790(17)320510(10)65416980, (01)00889024207806(17)320517(10)65416982, (01)00889024207806(17)320528(10)65424129, (01)00889024207806(17)320603(10)65439425, (01)00889024207790(17)320607(10)65439423, (01)00889024207813(17)320607(10)65439427, (01)00889024207806(17)320613(10)65447051, (01)00889024207790(17)320614(10)65447049, (01)00889024207806(17)320621(10)65460281, (01)00889024207790(17)320627(10)65474103, (01)00889024207806(17)320715(10)65486266, (01)00889024207806(17)320727(10)65521956, (01)00889024207806(17)320815(10)65559114, (01)00889024207790(17)320820(10)65559112, (01)00889024207813(17)320830(10)65573605, (01)00889024207806(17)320901(10)65573604, (01)00889024207813(17)320919(10)65602373, (01)00889024207806(17)320920(10)65594083, (01)00889024207820(17)320920(10)65602376, (01)00889024207806(17)321007(10)65611118, (01)00889024207790(17)321016(10)65696513, (01)00889024207806(17)330328(10)65617532, (01)00889024207806(17)330328(10)65625154, (01)00889024207806(17)330404(10)65751453, (01)00889024207806(17)330416(10)65738055, (01)00889024207806(17)330506(10)66005557, (01)00889024207806(17)330513(10)66005559, (01)00889024207806(17)330522(10)11025242, (01)00889024207806(17)330528(10)66005554, (01)00889024207790(17)331029(10)66324843, (01)00889024207806(17)331107(10)66324859, (01)00889024207790(17)331111(10)66324849, (01)00889024207790(17)331126(10)66324846, (01)00889024207806(17)331127(10)66324856, (01)00889024207790(17)331201(10)66324852, (01)00889024207806(17)331203(10)66324862, (01)00889024207790(17)331208(10)66378806, (01)00889024207790(17)331212(10)66364015, (01)00889024207820(17)340110(10)66378834, (01)00889024207806(17)340113(10)66364020; Lot Code: 64115713, 64175075, 64175076, 64175073, 64138317, 64175074, 64194991, 64202116, 64178998, 64179054, 64202117, 64179043, 64194989, 64178996, 64178997, 64179023, 64178999, 64179043R, 64194989R, 64202115, 64226003, 64226007, 64226008, 64220651, 64226001, 64226006, 64202119, 64226002, 64202118, 64254389, 64254390, 64226077, 64226078, 64226009, 64226076, 64254387, 64254388, 64261032, 64226129, 64242244, 64254386, 64226076R, 64254386R, 64254387R, 64261030, 64275592, 64275434, 64261033, 64261035, 64261031, 64275593, 64261029, 64275538, 64275540, 64261037, 64261036, 64275537, 64275435, 64275433, 64275541, 64261036R, 64261031R, 64275593R, 64294621, 64306997, 64302414, 64306991, 64302416, 64306994, 64302415, 64275591, 64275432, 64306994R, 64302415R, 64302414R, 64346982, 64334419, 64306995, 64261034, 64306992, 64306993, 64306996, 64334418, 64334420, 64306992R, 64306993R, 64306996R, 64346981, 64367312, 64367404, 64346996, 64367314, 64334415, 64334416, 64346995, 64367311, 64367311R, 64367403, 64367313, 64408081, 64367316, 64367318, 64400527, 64406831, 64406829, 64400526, 64406828, 64406830, 64406827, 64442403, 64414262, 64442404, 64442405, 64442407, 64442406, 64442407R, 64442408, 64480241, 64500130, 77009443, 64480265, 64540911, 64480242, 64480243, 64480264, 64480244, 64575335, 64575349, 64575359, 64575350, 64540917, 64575340, 64579745, 64579720, 64597631, 64597589, 64597633, 64597617, 64597632, 64675420, 64597618, 64675429, 64675430, 64699333, 64675440, 64675436, 64699359, 64699328, 64699369, 64699370, 64699352, 64675448, 64699392, 64699383, 64699391, 11024790, 64699406, 64808827, 64808820, 64825317, 64808824, 64808826, 64808835, 64827305, 64827304, 64808843, 64808850, 64808849, 64808858, 64808839, 64808866, 64808878, 64808873, 64808879, 64808887, 64808893, 64928262, 64928265, 64928264, 64827306, 64928273, 64928272, 64928279, 64928281, 64928290, 64928292, 64928301, 64928310, 64928316, 64928312, 64928325, 64928326, 64928337, 64928336, 64928345, 65038141, 65038133, 65038134, 65038135, 65038145, 65038144, 65038149, 65038142, 65038150, 65038154, 65038158, 65038140, 65038159, 65038162, 65038168, 65038169, 65038170, 65038171, 65038178, 65038182, 65038179, 65038137, 65038138, 65038139, 65038136, 65081582, 65081588, 65081597, 65117638, 65117642, 65117654, 65203277, 65203273, 65117670, 65117659, 65203270, 65203271, 65203283, 65203279, 65117658, 65117669, 65117682, 65346422, 65356469, 65356467, 65384861, 65397002, 65403274, 65410849, 65416980, 65416982, 65424129, 65439425, 65439423, 65439427, 65447051, 65447049, 65460281, 65474103, 65486266, 65521956, 65559114, 65559112, 65573605, 65573604, 65602373, 65594083, 65602376, 65611118, 65696513, 65617532, 65625154, 65751453, 65738055, 66005557, 66005559, 11025242, 66005554, 66324843, 66324859, 66324849, 66324846, 66324856, 66324852, 66324862, 66378806, 66364015, 66378834, 66364020.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

2 devices cleared under K031061 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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