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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement. Lot Numbers: 10723, 10763, 10824 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 36 units Z-2375-2012
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. Lot Numbers: 8396, 8989, 9225, 10316, 10713, 11571, 11669 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 182 units Z-2374-2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement. Lot Numbers: 8395,8823, 8929, 8969, 8984, 9166, 10319, 10740, 11703 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 270 units Z-2373-2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement. Lot Numbers: 8363, 8715, 8864, 8876, 8982, 9007, 9013, 9123, 9168, 10317 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 310 units Z-2372-2012
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. Lot Numbers: 8362, 8524, 8853, 8988, 8992, 9021, 9040, 9152, 9883, 9885, 10221, 10318, 10726, 11478 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 286 units Z-2371-2012
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement. Lot Numbers: 8361, 8525, 8894,8930, 8975, 9167, 9169, 10220, 10313, 10717, 11547 Class II The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility 312 units Z-2370-2012
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