Z-2374-2012 Class II Terminated
FDA device recall Z-2374-2012 was initiated by Omni Life Science on August 9, 2012 and is designated Class II. Reason for recall: The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility The recall status is terminated (terminated January 10, 2013). Affected quantity: 182 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 19, 2012
- Initiation Date
- August 9, 2012
- Termination Date
- January 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 182 units
Product Description
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Reason for Recall
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
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.
Code Information
Lot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669