BEUDAMED
    FDA Enforcement Class II Terminated

    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

    Recall: Z-0983-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0983-2015
    Event ID
    70070
    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

    Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.

    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.

    Code Info

    LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205

    Distribution

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

    Quantity

    14 units