Device product
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Z-0275-2016
Product summary
- Firm
- Medacta Usa
- Event
- Event 71121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units (US)
- Official record key
device-enforcement:Z-0275-2016
Official wording
Reason: Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Code information: Lot: 145129
Distribution pattern: Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
Derived failure modes
-
Unknown
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.