Home / Recalls / Medical Devices
Medacta Usa recalls GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Recalled November 25, 2015 · FDA recall Z-0275-2016 · Medacta Usa
Hazard
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws. · FDA Class II
Units
4 units (US)
Sold at
Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
Description
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Product
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Manufacturer(s)
Medacta Usa
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →