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Omni Life Science recalls Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intende
Recalled September 19, 2012 · FDA recall Z-2374-2012 · Omni Life Science
Hazard
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility · FDA Class II
Units
182 units
Sold at
Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
Description
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Product
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.
Manufacturer(s)
Omni Life Science
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →