BEUDAMED
    FDA Enforcement Class II Terminated

    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.

    Recall: Z-0952-2013 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0952-2013
    Event ID
    64330
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Extremity Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    January 10, 2013
    Classification Date
    March 15, 2013
    Termination Date
    July 18, 2013
    Address
    300 Interpace Pkwy Ste 410A, N/A, Parsippany, NJ, 07054-1148, United States

    Description

    Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge.

    Reason

    The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.

    Code Info

    Catalog Number 101-00006; Lot Number 00921538.

    Distribution

    Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.

    Quantity

    238 units