BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2375-2012 · Initiated August 9, 2012

    Recall

    Recall Number
    Z-2375-2012
    Event Number
    62912
    Firm
    Omni Life Science
    FEI Number
    3008342029
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    August 9, 2012
    Posted
    September 13, 2012
    Terminated
    January 10, 2013
    Address
    50 Oconnell Way, Unit 10, East Taunton, MA, 02718

    Description

    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.

    Reason

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

    Action

    Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845.

    Distribution

    Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands.

    Quantity

    36 units