Z-0275-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2015
- Initiation Date
- April 17, 2015
- Termination Date
- January 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units (US)
Product Description
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Reason for Recall
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Distribution Pattern
Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
Code Information
Lot: 145129