Events

Recall of Device Recall Right Long Tactile Probe

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
    61173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1190-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107459
  • 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
    When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. these probes are approved for use in the lumbar vertebra.
  • Action
    An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the letter.

Device

Device Recall Right Long Tactile Probe
  • Model / Serial
    Part Number 962011S: Lot Numbers 090106, 071219
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Republic of South Korea.
  • Product Description
    Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. || Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA