BEUDAMED
    FDA Enforcement Class III Terminated

    OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

    Recall: Z-0879-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0879-2017
    Event ID
    75758
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 28, 2016
    Initiation Date
    November 18, 2016
    Classification Date
    December 22, 2016
    Termination Date
    July 27, 2017
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

    Reason

    Labeled as a 48mm Cortical Screw but measuring at 50mm

    Code Info

    Product Number: 10-1500-3048 Lot Number: 161421-G

    Distribution

    Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.

    Quantity

    22 units