BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

    Recall: Z-2057-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2057-2012
    Event ID
    62351
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 1, 2012
    Initiation Date
    June 14, 2012
    Classification Date
    July 20, 2012
    Termination Date
    April 30, 2013
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001, United States

    Description

    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

    Reason

    The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

    Code Info

    Lot number: 7736703 and part number: 00-1050-4308

    Distribution

    Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.

    Quantity

    15 devices