NexGen CR-Flex Femoral Component — Class II medical device recall Z-1608-2024
Ongoing recall by Zimmer, Inc., reported 2024-05-01, distributed nationwide. Out of specification violation of devices that results in a gap existing within the fixture that presses the f
| Recall number | Z-1608-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2024-03-28 |
| Classified | 2024-04-22 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, JP, NL |
| Quantity | 5,546 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00889024207790, 00889024207806, 00889024207813, 00889024207820 |
| Lot numbers | 11024790, 11025242, 64115713, 64138317, 64175073, 64175074, 64175075, 64175076, 64178996, 64178997, 64178998, 64178999, 64179023, 64179043, 64179043R, 64179054, 64194989, 64194989R, 64194991, 64202115, 64202116, 64202117, 64202118, 64202119, 64220651, 64226001, 64226002, 64226003, 64226006, 64226007, 64226008, 64226009, 64226076, 64226076R, 64226077, 64226078, 64226129, 64242244, 64254386, 64254386R and 244 more |
| Model numbers | 00595201501, 00595201502, 00595201505, 00595201506 |
Product
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1608-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.