TRIGEN — Class II medical device recall Z-2685-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-07-29. A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (
| Recall number | Z-2685-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2020-06-24 |
| Classified | 2020-07-22 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2021-04-28 |
| Countries outside the US | AE, BR, CO |
| Quantity | 12 units |
| Lot numbers | 19BM13592A |
| Model numbers | 71655139 |
Product
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
Reason for recall
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
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-2685-2020. 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.