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 Hip System Model Recalled by OMNIlife science Inc. Due to Stems missing porous coating on the device.

Date: September 11, 2019
Company: OMNIlife science Inc.
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 Inc. directly.

Affected Products

OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

Quantity: 3 units

Why Was This Recalled?

Stems missing porous coating on the device.

Where Was This Sold?

This product was distributed to 2 states: IL, OK

Affected (2 states)Not affected

About OMNIlife science Inc.

OMNIlife science Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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