BEUDAMED
    FDA Recall Terminated

    ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085

    Recall: Z-1186-06 · Initiated June 7, 2006

    Recall

    Recall Number
    Z-1186-06
    Event Number
    35648
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    KOG
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 7, 2006
    Posted
    June 27, 2006
    Terminated
    November 21, 2006
    Address
    680 Vaqueros Ave, Sunnyvale, CA, 94085-3523

    Description

    ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085

    Reason

    Potential loss of product sterility due to breach of pouch seal.

    Action

    Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery.

    Distribution

    Worldwide