Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
- Recalling company
- Smith & Nephew, Inc.
- Product
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 16, 2026
- Reported
- Jun 24, 2026
- Distribution
- International distribution to the countries of BE, DE, IT.
- Status
- Ongoing
- Quantity
- 5
- Lot / codes
- UDI-DI: 03596010514394. Lot/Batch: 25BM03616
- Company location
- Memphis, TN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2456-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2456-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.