TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 — Class II medical device recall Z-2456-2026
Ongoing recall by Smith & Nephew, Inc., reported 2026-06-24. Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surger
| Recall number | Z-2456-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2026-03-16 |
| Classified | 2026-06-16 |
| Reported by FDA | 2026-06-24 |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 03596010514394 |
| Lot numbers | 25BM03616 |
| Model numbers | 71760816 |
Product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Reason for recall
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
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-2456-2026. 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.