BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    Recall: Z-0954-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0954-2013
    Event ID
    64452
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    February 7, 2013
    Classification Date
    March 15, 2013
    Termination Date
    December 7, 2015
    Address
    100 Interpace Pkwy, N/A, Parsippany, NJ, 07054-1149, United States

    Description

    Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.

    Reason

    Increased risk of failure at the driver tip during screw insertion or removal.

    Code Info

    Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

    Distribution

    Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.

    Quantity

    59 units.