BEUDAMED
    FDA Recall 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 · Initiated April 13, 2011

    Recall

    Recall Number
    Z-0344-2013
    Event Number
    62916
    Firm
    Extremity Medical LLC
    FEI Number
    3007289093
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 13, 2011
    Posted
    November 18, 2012
    Terminated
    March 21, 2013
    Address
    300 Interpace Pkwy, Ste 410A, Parsippany, NJ, 07054-1148

    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.

    Action

    Extremity Medical sent an e-mail notification (Extremity Medical- Sales Bulletin- IO Fix) dated April 13, 2011 to distributors notifying them of a change made to the 4.0 mm Lag Screw.

    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