BEUDAMED
    FDA Enforcement Class II Terminated

    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

    Recall: Z-1466-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1466-2015
    Event ID
    70832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 12, 2015
    Classification Date
    April 20, 2015
    Termination Date
    September 16, 2015
    Address
    310 Interlocken Pkwy Ste 120, Broomfield, CO, 80021-3464, United States

    Description

    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.

    Reason

    Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.

    Code Info

    538133,538134,548080,550475,552169,553131,553710,558873,567568,569141 Part Number: 6200-1109 2009300344 to 2009300543 2009300544 to 2009300643 2009300644 to 2009300743 2009300744 to 2009300843 2009300844 to 2009300993 2009411328 to 2009411377 2010082160 to 2010082257 2010152507 to 2010152571 2010373025 to 2010373174

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    874