BEUDAMED
    FDA Enforcement Class II Terminated

    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.

    Recall: Z-0752-2013 · Reported February 6, 2013

    Enforcement

    Recall Number
    Z-0752-2013
    Event ID
    63805
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Extremity Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 6, 2013
    Initiation Date
    March 22, 2012
    Classification Date
    January 30, 2013
    Termination Date
    June 13, 2013
    Address
    300 Interpace Pkwy Ste 410A, Parsippany, NJ, 07054-1148, United States

    Description

    Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.

    Reason

    Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).

    Code Info

    Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08

    Distribution

    Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.

    Quantity

    93 units