Z-2456-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- March 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
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.
Distribution Pattern
International distribution to the countries of BE, DE, IT.
Code Information
UDI-DI: 03596010514394. Lot/Batch: 25BM03616