BEUDAMED
    FDA Recall Terminated

    Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: www.ethicon.com

    Recall: Z-0246-04 · Initiated October 30, 2003

    Recall

    Recall Number
    Z-0246-04
    Event Number
    27613
    Firm
    Q-Med Corporation
    FEI Number
    3003157840
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 30, 2003
    Posted
    December 18, 2003
    Terminated
    July 11, 2012
    Address
    3801 SW 30th Ave, Ft Lauderdale, FL, 33312-6819

    Description

    Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: www.ethicon.com

    Reason

    This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.

    Action

    The firm e-mailed a Recall Notification Letter to the three wholesalers on 10/30/03 and also had telephone conversations with each of them concerning the recall. Their letter advises the accounts to subrecall down to the healthcare professional user level and also to quarantine suspect product. They also state: 'You should return any prolene mesh product to us if you are unsure whether the product you bought from us is authentic or counterfeit. '

    Distribution

    Product was distributed to three wholesalers in Virginia and one in Illinois.

    Quantity

    1057 boxes of six devices each