BEUDAMED
    FDA Recall 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 · Initiated August 22, 2013

    Recall

    Recall Number
    Z-0982-2015
    Event Number
    70056
    Firm
    Biomet Spine, LLC
    FEI Number
    3012447612
    Product Code
    OVD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 22, 2013
    Posted
    January 15, 2015
    Terminated
    March 13, 2015
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    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.

    Action

    Distributors and Direct Sales Reps notified via letter to return product.

    Distribution

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

    Quantity

    15