Worldwide Distribution -- US and Republic of South Korea.
Description du dispositif
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.
“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.
Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
Description du dispositif
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.