Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OMNI K2 Hip Stem Recalled by OmniLife Science Due to The device is missing grit blasting on the...

Date: October 1, 2021
Company: OmniLife Science
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OmniLife Science directly.

Affected Products

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.

Quantity: 7

Why Was This 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.

Where Was This Sold?

US Distribution to states of: Colorado and Virginia.

About OmniLife Science

OmniLife Science has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report