BEUDAMED
    FDA Recall Terminated

    Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.

    Recall: Z-1037-2012 · Initiated February 6, 2012

    Recall

    Recall Number
    Z-1037-2012
    Event Number
    61117
    Firm
    Orthofix, Inc.
    FEI Number
    2183449
    Product Code
    max
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2012
    Posted
    February 15, 2012
    Terminated
    June 11, 2012
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    Description

    Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.

    Reason

    The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.

    Action

    Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.

    Distribution

    Nationwide and Puerto Rico

    Quantity

    52