Events

Recall of thoracolumbosacral pedicle screw system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OrthoPediatrics Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79067
  • Event Risk Class
    Class 2
  • Event Number
    Z-0597-2018
  • Event Initiated Date
    2017-08-03
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161268
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pedicle screw spinal system, adolescent idiopathic scoliosis - Product Code OSH
  • 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 logistics@orthopediatrics.com or calling (574) 268-3692

Device

thoracolumbosacral pedicle screw system
  • Model / Serial
    Model number: 00-1300-0740, Lot number: M82791-1
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Response 5.5/6.0 Spine System 7.0mm x 40mm || Pedicle Screw || Product Usage: || Posterior non-cervical pedicle screw fixation
  • Manufacturer
    OrthoPediatrics Corp

Manufacturer

OrthoPediatrics Corp
  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
    Orthopediatrics Corp
  • Source
    USFDA