BEUDAMED
    FDA Enforcement Class II 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 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2375-2012
    Event ID
    62912
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omni Life Science
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 19, 2012
    Initiation Date
    August 9, 2012
    Classification Date
    September 13, 2012
    Termination Date
    January 10, 2013
    Address
    50 Oconnell Way, Unit 10, East Taunton, MA, 02718, United States

    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

    Code Info

    Lot Numbers: 10723, 10763, 10824

    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