Z-2456-2026 Class II Ongoing
FDA device recall Z-2456-2026 was initiated by Smith & Nephew, Inc. on March 16, 2026 and is designated Class II. 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 b… The recall status is ongoing. Affected quantity: 5.
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