Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary… — Class II medical device recall Z-2425-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-08-26, distributed in PR. The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be co
| Recall number | Z-2425-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-07-01 |
| Classified | 2015-08-20 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-08-18 |
| Distributed | PR |
| Countries outside the US | CA, CH, NZ |
| Quantity | 1,487 |
| Model numbers | 900.50, 900.51 |
Product
Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails; the Nail Wrap is intended to be used as a protective sheath specifically for Universal Femoral Nails, Universal Tibial Nails, Unreamed Tibial Nail, and the Stainless Steel Tibial Nail during steam sterilization by the hospital.
Reason for recall
The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.
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-2425-2015. 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.