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Recall Observatory FDA recall evidence

Device product

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

Z-2456-2026

March 16, 2026

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 98629
Status
Ongoing
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2456-2026

Official wording

Reason: 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.

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

Distribution pattern: International distribution to the countries of BE, DE, IT.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error

Field note

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