Z-0275-2016 Class II Terminated
FDA device recall Z-0275-2016 was initiated by Medacta Usa on Apr 17, 2015 and is designated Class II. 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. The recall status is terminated (terminated Jan 5, 2017). Affected quantity: 4 units (US).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 25, 2015
- Initiation Date
- Apr 17, 2015
- Termination Date
- Jan 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