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Recall Observatory FDA recall evidence

Device product

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

Z-2685-2020

June 24, 2020

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 85920
Status
Terminated
Classification
Class II
Quantity
12 units
Official record key
device-enforcement:Z-2685-2020

Official wording

Reason: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

Code information: Model: 71655139 Lot: 19BM13592A

Distribution pattern: International distribution in the countries of Brazil, Colombia and United Arab Emirates.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing error