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FDAMarch 16, 2026device

TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

03596010514394

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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