BEUDAMED
    FDA Recall 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 · Initiated April 25, 2011

    Recall

    Recall Number
    Z-0438-2013
    Event Number
    62918
    Firm
    Extremity Medical LLC
    FEI Number
    3007289093
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 25, 2011
    Posted
    November 26, 2012
    Terminated
    March 21, 2013
    Address
    300 Interpace Pkwy, Ste 410A, Parsippany, NJ, 07054-1148

    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.

    Action

    Extremity Medical sent a notification by e-mail that describes the "Slight modification to the Surgical Technique" on April 25, 2011. For questions regarading this recall call 973-588-8980.

    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