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

Recall date

April 17, 2015

Source

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

Recall number

Z-0275-2016

FDA classification

Class II

Brand / firm

Medacta Usa

Sold / distributed

Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.

Why it was recalled

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

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

What was recalled

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