Smith & Nephew TRIGEN humeral nail recalled for missing distal holes
What this means
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.
- 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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2456-2026Want us to check the next one for you?
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