Synthes Trochanteric Fixation Nail As part of the Synthes… — Class II medical device recall Z-0474-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-18, distributed nationwide. Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the le
| Recall number | Z-0474-2014 |
|---|---|
| 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 | 2013-12-10 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 12 |
| Reason classes | labeling |
| Lot numbers | 7121831, 7121832 |
| Model numbers | 456.475S, 456.637S |
| Expiration dates | 2021-11-30 |
Product
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Reason for recall
Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
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-0474-2014. 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.