FDA Device recall Z-1352-2015
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm by Synthes, citing the guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1352-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-24 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Reason
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Identifiers
| code_info | Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 91240…Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563 |
|---|
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-1352-2015%22
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