BEUDAMED
    FDA Recall Terminated

    OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    Recall: Z-0611-2012 · Initiated August 8, 2011

    Recall

    Recall Number
    Z-0611-2012
    Event Number
    60049
    Firm
    Innovatech Medical Resources L.P.
    FEI Number
    3009124511
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    August 8, 2011
    Posted
    January 11, 2012
    Terminated
    September 27, 2012
    Address
    5455 Honeysuckle Road, Midlothian, TX, 76065

    Description

    OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

    Reason

    Product is being removed from the field due to an over-label issue.

    Action

    Innovatech Medical Resources L.P. decided to recall all products resterilized and overlabeled at their facility. A firm representative would visit each customer and request that they remove the overlabeled product from their shelves and secure it. Customers could call the MSI office to get a RMA (Return Materials Authorization) for a refund on this product. For questions regarding this recall call 817-714-9066.

    Distribution

    Nationwide Distribution including Texas

    Quantity

    Lot Number (QTY): 1000044 (17 units) and 1000162 (10 units)