Recall
FDAHealthMarch 16, 2026

Smith & Nephew, Inc. — 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.

Is this relevant to me?

Geography
BE, DE, IT
Source agency
FDA
Category
Health
Published
March 16, 2026

International distribution to the countries of BE, DE, IT.

What's affected?

Product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Lot code
/Batch:

Additional details

UDI-DI: 03596010514394. Lot/Batch: 25BM03616

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 5.

View original FDA notice →

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