FDAHealthMarch 16, 2026
Smith & Nephew, Inc. — TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
⚠️ 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.
Is this relevant to me?
- Geography
- BE, DE, IT
- Source agency
- FDA
- Category
- Health
- Published
- March 16, 2026
International distribution to the countries of BE, DE, IT.
What's affected?
- Product
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Brand
- Smith & Nephew, Inc.
- Lot code
- /Batch:
Additional details
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5.
Get Health recall alerts
Delivered to your inbox. Free. No account required.