BEUDAMED
    FDA Enforcement Class II Terminated

    IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

    Recall: Z-0438-2013 · Reported December 5, 2012

    Enforcement

    Recall Number
    Z-0438-2013
    Event ID
    62918
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Extremity Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 5, 2012
    Initiation Date
    April 25, 2011
    Classification Date
    November 26, 2012
    Termination Date
    March 21, 2013
    Address
    300 Interpace Pkwy Ste 410A, N/A, Parsippany, NJ, 07054-1148, United States

    Description

    IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

    Reason

    Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

    Code Info

    Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.

    Distribution

    Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.

    Quantity

    156 units