BEUDAMED
    FDA Enforcement Class II Terminated

    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.

    Recall: Z-0344-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0344-2013
    Event ID
    62916
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Extremity Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 28, 2012
    Initiation Date
    April 13, 2011
    Classification Date
    November 17, 2012
    Termination Date
    March 21, 2013
    Address
    300 Interpace Pkwy Ste 410A, N/A, Parsippany, NJ, 07054-1148, United States

    Description

    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.

    Reason

    Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.

    Code Info

    Product coding is listed as Catalog Number: Lot Number and are as follows: 118-30014:107509; 118-30016:107510; 118-30018:107511; 118-30020:107512; 118-30020:107513; 118-30022:107514; 118-30024:107515; 118-30026:107516; 118-40020:107457; 118-40025:107458; 118-40030;107529; 118-40030;107459; 118-40035:107460; 118-40040:107461; 118-40045:107462; 118-40050:107463; 118-40320:107613; 118-40325:107614; 118-40330:107615; 118-40330:107616; 118-40335:107617; 118-40340:107618; 118-40345:107619; 118-40350:107620.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE, and the country of Switzerland.

    Quantity

    120 Units