BEUDAMED
    FDA Recall Terminated

    ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

    Recall: Z-1952-2011 · Initiated September 30, 2010

    Recall

    Recall Number
    Z-1952-2011
    Event Number
    57830
    Firm
    ArthroCare Corporation
    FEI Number
    3010813691
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 30, 2010
    Posted
    April 12, 2011
    Terminated
    August 1, 2011
    Address
    680 Vaqueros Ave, Sunnyvale, CA, 94085-3523

    Description

    ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.

    Reason

    During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.

    Action

    On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Product was released for distribution in US.

    Quantity

    170 units