TFN-ADVANCED Proximal Femoral Nailing System — Class II medical device recall Z-1600-2015
Terminated recall by Synthes, Inc., reported 2015-05-20, distributed nationwide. TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potenti
| Recall number | Z-1600-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-04-09 |
| Classified | 2015-05-12 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 8,175 |
| Lot numbers | 7704282, 7704284, 7704285, 7704287, 7704844, 7704923, 7705575, 7705576, 7705577, 7705578, 7705986, 7706822, 7706823, 7706824, 7706826, 7707496, 7707497, 7707498, 7707500, 7708184, 7708185, 7708186, 7708187, 7708614, 7708615, 7708616, 7708617, 7708824, 7709787, 7709792, 7709793, 7709799, 7709804, 7709807, 7709814, 7709818, 7709819, 7709824, 7709825, 7709826 and 460 more |
| Model numbers | 04.037.012S, 04.037.013S, 04.037.014S, 04.037.015S, 04.037.017S, 04.037.019S, 04.037.021S, 04.037.023S, 04.037.025S, 04.037.027S, 04.037.028S, 04.037.029S, 04.037.031S, 04.037.033S, 04.037.035S, 04.037.037S, 04.037.039S, 04.037.042S, 04.037.043S, 04.037.044S, 04.037.045S, 04.037.050S, 04.037.051S, 04.037.052S, 04.037.053S and 143 more |
Product
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Reason for recall
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1600-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.