BEUDAMED
    FDA Recall Terminated

    FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

    Recall: Z-0798-06 · Initiated March 24, 2006

    Recall

    Recall Number
    Z-0798-06
    Event Number
    35033
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    KGS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2006
    Posted
    April 26, 2006
    Terminated
    December 12, 2007
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

    Reason

    The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor.

    Action

    Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.

    Distribution

    Nationwide Foreign: Austria, Germany, France, Italy, Australia

    Quantity

    1800 units