Synthes (USA) Products LLC Recall 91702
Description: TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
Synthes (USA) Products LLC Recall 91702 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1246-2023 |
| Event ID | 91702 |
| Event Description | TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. |
| Quantity | 6 units |
| Recall Reason | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length |
| Device Classification | 20230322 |
| Device Code Info | UDI-DI 10886982097033 Lot Number: 607P512 |
| Center Classification Date | 20230310 |
| Recall Initiation Date | 20230201 |
| Recalling Firm | Synthes (USA) Products LLC |
| Initial Notification | Letter |
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