Exactech, Inc. Recall 88259
Description: Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Exactech, Inc. Recall 88259 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2251-2021 |
| Event ID | 88259 |
| Event Description | Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component. |
| Product Type | Devices |
| Distribution | US Nationwide Distribution |
| Quantity | 30 devices |
| Recall Reason | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 10-36-03 (36mm +3.5). |
| Device Classification | 20210818 |
| Device Code Info | Serial Numbers: 6465619-6465640; 6465642-6465648 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210629 |
| Recalling Firm | Exactech, Inc. |
| Initial Notification | |
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