BEUDAMED
    FDA Enforcement Class II Terminated

    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

    Recall: Z-0597-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0597-2018
    Event ID
    79067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 21, 2018
    Initiation Date
    August 3, 2017
    Classification Date
    February 13, 2018
    Termination Date
    May 8, 2019
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001, United States

    Description

    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

    Reason

    The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

    Code Info

    Model number: 00-1300-0740, Lot number: M82791-1

    Distribution

    US Nationwide Distribution

    Quantity

    24 units