BEUDAMED
    FDA Recall 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 · Initiated August 3, 2017

    Recall

    Recall Number
    Z-0597-2018
    Event Number
    79067
    Firm
    OrthoPediatrics Corp
    FEI Number
    3006460162
    Product Code
    OSH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 3, 2017
    Terminated
    May 8, 2019
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001

    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.

    Action

    On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to [email protected] or calling (574) 268-3692

    Distribution

    US Nationwide Distribution

    Quantity

    24 units