BEUDAMED
    FDA Enforcement Class II Terminated

    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    Recall: Z-2454-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2454-2015
    Event ID
    71470
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omnilife Science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    June 9, 2015
    Classification Date
    August 24, 2015
    Termination Date
    September 28, 2015
    Address
    50 Oconnell Way Ste 10, N/A, East Taunton, MA, 02718-1394, United States

    Description

    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    Reason

    The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

    Code Info

    Lot Numbers: MM0314R, VA0713, Z1111

    Distribution

    Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.

    Quantity

    15