FDA-Device2015-11-25Class II
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
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.
Sold states
Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
Affected count
4 units (US)
Manufactured in
1556 W Carroll Ave, N/A, Chicago, IL, United States
Products
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0275-2016Don't want to check this manually?
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