BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

    Recall: Z-1547-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1547-2013
    Event ID
    65210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2013
    Initiation Date
    April 29, 2013
    Classification Date
    June 14, 2013
    Termination Date
    May 6, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

    Reason

    Biomet Trauma ("Biomet") has initiated a recall of Retrograde Femoral Connecting Bolt, which involves Part Number 14-442021. The connecting bolt has an undersized diameter specification that may cause an interference fit with the 4mm hex driver (Part Number: 41024) near the edge of the tolerance. If the 4mm hex driver becomes stuck in the connecting bolt it cannot be taken apart and a delay in su

    Code Info

    Catalog number: 14-442021 and lot number:757910

    Distribution

    Worldwide Distribution - USA Nationwide: CA, TX, NY, PA, NJ, FL, OH, MI, CO, SD, IN, MT, GA, and WI. and the countries of Netherlands, Costa Rica, Japan, and San Juan.

    Quantity

    75