Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
FDA device recall Z-2251-2021 · posted 2021-08-12 · Completed
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- LZO
- Quantity affected
- 30 devices
- Distribution
- US Nationwide Distribution
- Date initiated
- 2021-06-29
- Date posted
- 2021-08-12
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS (K060107) | Exactech, Inc. | 2006-02-06 |