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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012
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Product Detail

Product Description 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.
Recall Number Z-2371-2012
Classification Class II
Code Info Lot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478
Product Distributed Qty 286 units
Reason For Recall The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility

Event Detail

Event Id 62912
Product Type Devices
Status Ongoing
Recalling Firm Omni Life Science
City East Taunton
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-09
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.
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