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…

Recall date

October 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0237-2022

FDA classification

Class II

Brand / firm

OmniLife Science

Sold / distributed

US Distribution to states of: Colorado and Virginia.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.