FDAFDA · Food and drugs·Recall number Z-2456-2026
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Published June 24, 2026 · Recall initiated: March 16, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- International distribution to the countries of BE, DE, IT.
- Lot
- UDI-DI: 03596010514394. Lot/Batch: 25BM03616
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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