BEUDAMED
    FDA Recall Terminated

    Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

    Recall: Z-0149-2007 · Initiated June 20, 2006

    Recall

    Recall Number
    Z-0149-2007
    Event Number
    36234
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2006
    Posted
    November 8, 2006
    Terminated
    December 13, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

    Reason

    Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.

    Action

    Notification will take place to the wholesale (agent) level via telephone calls from PLUS USA''s Customer Service Department on/or about June 20, 2006. Each location will be contacted to determine if they have any affected devices. If so, they will be issued an RMA with the request to return any affected devices as soon as possible. Returned devices will be sent to the manufacturer for repair.

    Distribution

    Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI

    Quantity

    31