BEUDAMED
    FDA Enforcement Class II Terminated

    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    Recall: Z-0982-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0982-2015
    Event ID
    70056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 21, 2015
    Initiation Date
    August 22, 2013
    Classification Date
    January 15, 2015
    Termination Date
    March 13, 2015
    Address
    310 Interlocken Pkwy Ste 120, Broomfield, CO, 80021-3464, United States

    Description

    Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    Reason

    The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.

    Code Info

    Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013

    Distribution

    Distributed in PR and the states of NY, AZ, TN, TX, and CA.

    Quantity

    15