BEUDAMED
    FDA Recall Terminated

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    Recall: Z-1081-2007 · Initiated June 19, 2007

    Recall

    Recall Number
    Z-1081-2007
    Event Number
    38261
    Firm
    Synovis Surgical Inovation Div. of
    FEI Number
    2183620
    Product Code
    GDF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2007
    Posted
    July 24, 2007
    Terminated
    May 8, 2012
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalgo ref. 4-12GPS. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 12mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024

    Reason

    There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.

    Action

    Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.

    Distribution

    Nationwide.

    Quantity

    6 boxes (24 units)