Events

Recall of Device Recall Vertex Max Drill Tube

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

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
    57549
  • Event Risk Class
    Class 2
  • Event Number
    Z-1042-2011
  • Event Initiated Date
    2010-12-15
  • Event Date Posted
    2011-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96537
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Reason
    Incorrectly manufactured drill tube could cause incorrect screw placement during spinal surgery.
  • Action
    Consignees were notified by a Product Correction Notification letter on 12/15/2010 and given the affected product and a description of the problem. The letter stated that a Medtronic representative would contact customers to visit their facility and replace the affected guide with one that has been correctly manufactured. Additional information is available at 800-595-9709.

Device

Device Recall Vertex Max Drill Tube
  • Model / Serial
    Lot number: 100721
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of GA, IL, IN, MN, MO, OH, OR, PA, and TX and countries of Denmark, Finland, Singapore, Spain, and UK.
  • Product Description
    Vertex Max Drill Tube, Catalog Number 9733140, a component of the Navigated Vertex Max Drill Guide Kit, Catalog Number 9733370. Medtronic, Inc., Louisville, CO. || Used in conjunction with the StealthStation navigation systems to assist in screw placement during spine surgery.
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

Medtronic Navigation, Inc
  • Manufacturer Address
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA