BEUDAMED
    FDA Enforcement Class II Terminated

    Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.

    Recall: Z-1043-2016 · Reported March 9, 2016

    Enforcement

    Recall Number
    Z-1043-2016
    Event ID
    72853
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 9, 2016
    Initiation Date
    November 30, 2015
    Classification Date
    March 3, 2016
    Termination Date
    October 13, 2016
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.

    Reason

    Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.

    Code Info

    All codes

    Distribution

    US Nationwide Distribution

    Quantity

    1232