CoCr Femoral Head — Class II medical device recall Z-1294-2023
Ongoing recall by Zimmer, Inc., reported 2023-04-05, distributed in AL, AZ, CO, FL, LA, MI, OH, OK…. Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS-
| Recall number | Z-1294-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2023-02-27 |
| Classified | 2023-03-29 |
| Reported by FDA | 2023-04-05 |
| Distributed | AL, AZ, CO, FL, LA, MI, OH, OK, TX |
| Countries outside the US | CA |
| Quantity | 1,168 untits |
| UPC / GTIN / UDI-DI | 00889024283268 |
| Model numbers | 01.01012.384 |
Product
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
Reason for recall
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
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-1294-2023. 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.