BEUDAMED
    FDA Recall Terminated

    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    Recall: Z-0978-2015 · Initiated August 22, 2013

    Recall

    Recall Number
    Z-0978-2015
    Event Number
    70060
    Firm
    Biomet Spine, LLC
    FEI Number
    3012447612
    Product Code
    OVD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 22, 2013
    Posted
    January 14, 2015
    Terminated
    March 13, 2015
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    Description

    Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

    Reason

    The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.

    Action

    The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: [email protected].

    Distribution

    US Distribution to states of: AZ, CA, NY, TN, and TX including PR.

    Quantity

    12 units