BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

    Recall: Z-2759-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2759-2015
    Event ID
    71877
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet Spine, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2015
    Initiation Date
    July 22, 2015
    Classification Date
    September 10, 2015
    Termination Date
    December 10, 2015
    Address
    310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, 80021-3464, United States

    Description

    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

    Reason

    Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.

    Code Info

    P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220

    Distribution

    Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.

    Quantity

    49