Smith & Nephew TRIGEN humeral nail recalled for missing distal holes
Smith & Nephew identified a manufacturing error in certain TRIGEN Proximal Straight Humeral Nails (8/7 X 16, Ref: 71760816) in which the distal holes are missing. If implanted without detection, the affected nail could require revision surgery. Five units were distributed internationally.
From the FDA notice · Read the official notice ↗ · All Smith & Nephew recalls
What to do
- Inspect the humeral nail before implantation to confirm distal holes are present
- If missing holes are detected, do not use the affected nail
- Use an equivalent backup nail or contact Smith & Nephew for replacement
- Inform your surgical team if you have this product in stock
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
- Sold in
- International distribution to the countries of BE, DE, IT.
- Made for
- All ages (0 months and older)
Details
- Units affected
- 5
- Illnesses reported
- None reported
- Manufactured in
- 1450 E Brooks Rd, Memphis, TN, United States
- Classification
- Class II
- Recall number
- Z-2456-2026
In the FDA's words
- Description
- TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 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. UDI-DI: 03596010514394. Lot/Batch: 25BM03616 Distribution: International distribution to the countries of BE, DE, IT. Affected quantity: 5
- 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.
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ModerateFDAOct 30, 2026