Synthes Trauma Nail System — Class II medical device recall Z-2058-2013
Terminated recall by Synthes USA HQ, Inc., reported 2013-09-04, distributed nationwide. Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in t
| Recall number | Z-2058-2013 |
|---|---|
| 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 | 2012-11-02 |
| Classified | 2013-08-26 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,011,783 |
| Reason classes | sterility |
| Lot numbers | 7060897, 7072305 |
Product
Synthes Trauma Nail System. The devices are indication for bone fixation.
Reason for recall
Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
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-2058-2013. 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.