FDA Device recall Z-0375-2016
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System…
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System… by Synthes Usa Products, citing TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0375-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | CA, FL, MI, WI |
Product
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
Reason
TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism.
Identifiers
| code_info | Part Number Lot Number 04.037.162S 7950511 |
|---|
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-0375-2016%22
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