FDAFDA recall Z-2456-2026 · Jun 24, 2026
Smith & Nephew, Inc.: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16 recall
Recall found
Product
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 03596010514394. Lot/Batch: 25BM03616
- Quantity
- 5
- Distribution
- International distribution to the countries of BE, DE, IT.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-03-16
Source: openFDA enforcement record Z-2456-2026 · search recall number Z-2456-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.