Device product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Z-2373-2012
Product summary
- Event
- Event 62912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 units
- Official record key
device-enforcement:Z-2373-2012
Official wording
Reason: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Code information: Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703
Distribution pattern: Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
Derived failure modes
-
Unknown
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility