Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm — Class II medical device recall Z-1352-2015
Terminated recall by Synthes, Inc., reported 2015-04-08, distributed nationwide. The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instr
| Recall number | Z-1352-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-02-24 |
| Classified | 2015-03-30 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Quantity | 131 |
| Lot numbers | 8903848, 8918563, 8918566, 903851, 9124012, 9124014, 9124016, 9124017, 9124019, 9124022, 9124023, 9124026, 9124027 |
| Model numbers | 03.037.013, 03.037.014 |
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 for recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
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-1352-2015. 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.