Smith & Nephew, Inc.
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →