FDA-Device2012-09-19Class II
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Omni Life Science
Hazard
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Sold states
Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.
Affected count
286 units
Manufactured in
50 Oconnell Way, Unit 10, East Taunton, MA, United States
Products
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2371-2012Don't want to check this manually?
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