BEUDAMED
    FDA Recall 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 · Initiated March 12, 2015

    Recall

    Recall Number
    Z-1465-2015
    Event Number
    70832
    Firm
    Biomet Spine, LLC
    FEI Number
    3012447612
    Product Code
    HXC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 12, 2015
    Posted
    April 20, 2015
    Terminated
    September 16, 2015
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    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.

    Action

    Biomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    148