Recall Z-2250-2021 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
| Date | Aug 12, 2021 (initiated Jun 29, 2021) |
| Status | Completed |
| Reason | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). |
| Root cause | Under Investigation by firm |
| Action | The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021. |
| Quantity | 29 devices |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050398 | EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS Exactech, Inc., Nov 18, 2005 |