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Smith & Nephew, Inc.: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816

Medical DevicesSource: FDA (device) · Date: 2026-06-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Smith & Nephew, Inc.
Product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the countries of BE, DE, IT.
Recall initiated
2026-03-16
Code info
UDI-DI: 03596010514394. Lot/Batch: 25BM03616
Product quantity
5
Voluntary mandated
Voluntary: Firm initiated
City
Memphis
State
TN
Country
United States
Event id
98629
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