BEUDAMED
    FDA Enforcement Class II Terminated

    Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.

    Recall: Z-1465-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1465-2015
    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

    Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.

    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

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    148