Synthes Soft Tissue Retractor Small Extendible — Class II medical device recall Z-0429-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-12-11, distributed nationwide. The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
| Recall number | Z-0429-2014 |
|---|---|
| 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 | 2013-08-01 |
| Classified | 2013-11-29 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2015-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 374 |
| Reason classes | device malfunction |
| Model numbers | J5957AC, J5957F |
Product
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Reason for recall
The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
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-0429-2014. 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.