BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0536-2013 · Initiated September 29, 2012

    Recall

    Recall Number
    Z-0536-2013
    Event Number
    63653
    Firm
    Ebi, Llc
    FEI Number
    2242816
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 29, 2012
    Posted
    December 17, 2012
    Terminated
    December 7, 2015
    Address
    100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    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.

    Action

    Biomet mailed Urgent Medical Device Recall Notice/Fax Back Response Form dated 9/25/2012 to the distributors on 9/29/2012.

    Distribution

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

    Quantity

    15 units