FDA Device recall Z-1248-2023
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac…
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur frac… by Synthes Usa Products, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1248-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-01 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
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
Identifiers
| code_info | UDI-DI: 10886982097262 Lot Number: 610P788 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-10-29 · Synthes Usa Products - LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing…
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All Synthes Usa Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1248-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.