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Recall Observatory FDA recall evidence

Device product

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.

Z-2371-2012

August 09, 2012

Class II

Product summary

Firm
Omni Life Science
Event
Event 62912
Status
Terminated
Classification
Class II
Quantity
286 units
Official record key
device-enforcement:Z-2371-2012

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: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478

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

    reason.no_named_rule · v1.0.0

    The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility