BEUDAMED
    FDA Recall Terminated

    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***

    Recall: Z-0251-04 · Initiated November 3, 2003

    Recall

    Recall Number
    Z-0251-04
    Event Number
    27656
    Firm
    Owens & Minor Distribution, Inc.
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2003
    Posted
    December 18, 2003
    Terminated
    August 4, 2011
    Address
    4800 Cox Road Glen, Allen, VA, 23060

    Description

    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***

    Reason

    Counterfeit product is an unapproved medical device with associated potential health hazard.

    Action

    The distributor notified the firm's chain of warehouses by e-mail on 10/31/03 to identify, segregate and quarantine potential counterfeit product. The distributor then notified consignees by letter on 11/3/03. The letter advised that customers may have received 2 lots of counterfeit product and described the features for identity, which were provided by the manufacturer (www.ethicon.com) of the authentic product. The notification further instructed that appropriate healthcare professionals should be advised of the recall. Consignees were instructed to quarantine the specified lots for return.

    Distribution

    Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.

    Quantity

    CANNOT BE DETERMINED