BEUDAMED
    FDA Recall 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 · Initiated November 30, 2015

    Recall

    Recall Number
    Z-1043-2016
    Event Number
    72853
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    November 30, 2015
    Terminated
    October 13, 2016
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    Aesculap sent an Urgent Medical Device Correction letter to Distributors and Sales Rep. The letter identified the affected product, problem and actions to be taken. Customers were notified to add the over label to product packaging. Telephone conferences with Distributors and Sales Rep reiterated need for representative to inform Surgical Handler of the label when providing product for review. Customers were instructed to complete the attached Product Correction Acknowledgement Form and return to Aesculap Quality Assurance department by faxing the form to 610-791-6882 or e-mail to [email protected], two (2) weeks of receipt, even if the total inventory in your possession is zero (0).

    Distribution

    US Nationwide Distribution

    Quantity

    1232