Device Recall Right Long Tactile Probe

  • Model / Serial
    Part Number 962011S: Lot Numbers 090106, 071219
  • Product Classification
  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number 071219
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
  • Product Description
    Probe, Tactile, Right, ASM, Long, || Part #962011S, || Medtronic Navigation, || Louisville, CO 80027. || Trackable hand held 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