BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

    Recall: Z-0536-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0536-2013
    Event ID
    63653
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ebi, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    September 29, 2012
    Classification Date
    December 17, 2012
    Termination Date
    December 7, 2015
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149, United States

    Description

    Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

    Reason

    Broken screw insertor hardness was measured and found to be below the acceptable limits.

    Code Info

    Lot Numbers 540199, 540199-1

    Distribution

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

    Quantity

    15 units