Ceramic Femoral Head — Class II medical device recall Z-0825-2015
Terminated recall by DePuy Orthopaedics, Inc., reported 2014-12-24, distributed in AL, AZ, WV. Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code
| Recall number | Z-0825-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-11-07 |
| Classified | 2014-12-17 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-03-24 |
| Distributed | AL, AZ, WV |
| Countries outside the US | DE, FI |
| Quantity | 19 units |
| UPC / GTIN / UDI-DI | 10603295033684 |
| Lot numbers | 7928614 |
| Model numbers | 1365-36-740 |
Product
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Reason for recall
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
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-0825-2015. 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.