FDA Device recall Z-1600-2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA)
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of TFN-ADVANCED Proximal Femoral Nailing System (TFNA) by Synthes, citing TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1600-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-09 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Reason
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Identifiers
| code_info | Part 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…Part 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 04.037.054S 04.037.055S 04.037.056S 04.037.057S 04.037.058S 04.037.059S 04.037.060S 04.037.061S 04.037.062S 04.037.063S 04.037.064S 04.037.065S 04.037.066S 04.037.067S 04.037.068S 04.037.069S 04.037.112S 04.037.120S 04.037.121S 04.037.123S 04.037.125S 04.037.127S 04.037.129S 04.037.130S 04.037.131S 04.037.133S 04.037.135S 04.037.138S 04.037.142S 04.037.142S 04.037.143S 04.037.144S 04.037.145S 04.037.150S 04.037.151S 04.037.152S 04.037.153S 04.037.154S 04.037.155S 04.037.156S 04.037.157S 04.037.158S 04.037.159S 04.037.160S 04.037.161S 04.037.162S 04.037.163S 04.037.164S 04.037.165S 04.037.166S 04.037.167 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1600-2015%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.