Device product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Z-2370-2012
Product summary
- Event
- Event 62912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 312 units
- Official record key
device-enforcement:Z-2370-2012
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: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547
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