Events

Recall of Device Recall Knee navigation trackers.

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
    34604
  • Event Risk Class
    Class 3
  • Event Number
    Z-0718-06
  • Event Initiated Date
    2006-02-01
  • Event Date Posted
    2006-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44173
  • 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
    Knee navigation disposable kits were programmed with an incorrect identification number on the tracker rom chip which would not permit navigation during surgery.
  • Action
    Medtronic field personnel were notified by letter on 02/01/2006 and instructed to immediately contact each affected site and schedule an upgrade with the revised firmware

Device

Device Recall Knee navigation trackers.
  • Model / Serial
    Catalog Number: 9732140. Lot numbers 2005100642 and 2005100645.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, CO, GA, IL, LA, MT, NE, NV, OH, TX. No military or government distribution. Foreign distribution to Australia, Austria, Israel, Singapore, Switzerland, UK.
  • Product Description
    AxiEM EM Knee Kit, and associated workstation.
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

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