Class II — Potential Health Hazard

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

Omnilife Science Apex Knee System Modular Tibia Augment Recalled by Omni Life Science Due to The Apex Knee System Modular Tibia Augment may...

Date: August 9, 2012
Company: Omni Life 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 Omni Life Science directly.

Affected Products

Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.

Quantity: 182 units

Why Was This Recalled?

The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Omni Life Science

Omni Life Science has 6 total recalls tracked by RecallDetector.

Related Recalls

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