medical MODERATE Updated 2026-06-24

Smith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 7176081

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Recalled Product

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

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Hazard / Issue

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.

Issued by

FDA

Affected States: DE
Lot/Code Info: UDI-DI: 03596010514394. Lot/Batch: 25BM03616

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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