Reported Jun 24, 2026 · Ongoing
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Smith & Nephew, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804
Is this the product you have?
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16
- REF71760816
- Lot codes and dates
- UDI-DI03596010514394
- Lot/Batch25BM03616
- Amount recalled
- 5
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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