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OmniLife Science recalls OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component
Recalled November 24, 2021 · FDA recall Z-0237-2022 · OmniLife Science
Hazard
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing. · FDA Class II
Units
7
Sold at
US Distribution to states of: Colorado and Virginia.
Description
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Product
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Manufacturer(s)
OmniLife Science
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →