BEUDAMED
    FDA Enforcement Class II Terminated

    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

    Recall: Z-0411-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0411-2014
    Event ID
    66654
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    September 24, 2013
    Classification Date
    November 27, 2013
    Termination Date
    May 15, 2015
    Address
    100 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1149, United States

    Description

    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

    Reason

    Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.

    Code Info

    Device listing # D090878 Catalog # LV00407 Lot #184090

    Distribution

    US Distribution to CA

    Quantity

    2 units