Events

Recall of COLORADO 2" SPINAL SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

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
    44854
  • Event Risk Class
    Class 2
  • Event Number
    Z-0125-2008
  • Event Initiated Date
    2007-09-10
  • Event Date Posted
    2008-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64443
  • 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
    Spinal Implant Component - Product Code KWP
  • Reason
    Assembly may be compromised: two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.
  • Action
    Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.

Device

COLORADO 2" SPINAL SYSTEM
  • Model / Serial
    Lot Numbers: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809, and W07H1810.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.
  • Product Description
    Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.
  • Manufacturer
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Manufacturer

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
  • Manufacturer Address
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
  • Source
    USFDA