FDA Device recall Z-0825-2015
Ceramic Femoral Head
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of Ceramic Femoral Head by Depuy Orthopaedics, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0825-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-07 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | AL, AZ, WV |
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
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
Identifiers
| code_info | Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Depuy Orthopaedics
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FDA Device · Class II · 2024-04-10 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics - Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Device · Class II · 2023-03-29 · Depuy Orthopaedics
All Depuy Orthopaedics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2015%22
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