Titanium Trochanteric Fixation Nail — Class II medical device recall Z-0452-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-11, distributed nationwide. Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
| Recall number | Z-0452-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-07-30 |
| Classified | 2013-12-04 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 17 |
| Lot numbers | 5536930, 7161401 |
| Model numbers | 456.391S |
| Expiration dates | 2016-05-20, 2021-12-31 |
Product
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Reason for recall
Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
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-0452-2014. 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.