medical Class II Updated 2020-07-29

Smith & Nephew, Inc. recalls TRIGEN, Intramedullary nail - Product Usage: is intended to

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: International distribution in the countries of Brazil, Colombia and United Arab Emirates.
Lot/Code Info: Model: 71655139 Lot: 19BM13592A
View official government recall

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