Class II — Potential Health Hazard

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

GMK Hinge knee prosthesis Recalled by Medacta Usa Due to Incorrect parts: Packages of the GMK Hinge Tibial...

Date: April 17, 2015
Company: Medacta Usa
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 Medacta Usa directly.

Affected Products

GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

Quantity: 4 units (US)

Why Was This Recalled?

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

Where Was This Sold?

This product was distributed to 3 states: IL, OH, UT

Affected (3 states)Not affected

About Medacta Usa

Medacta Usa has 3 total recalls tracked by RecallDetector.

Related Recalls

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