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.
Worldwide distribution: USA including states of DC, IN, PA, and VA and country of Japan.
Description du dispositif
Vertex Max Drill Guide, Catalog Number 9732355, to be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures. || To be used with a Medtronic Computer-Assisted Surgery System to help assist with screw placement during spine procedures.
Worldwide Distribution -- USA, including VA, IA, MN and OK and countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Iceland, India, Israel, Italy, Japan, Korea, Lebanon, Malta, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK.
Description du dispositif
Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. || In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery.
Nationwide, including 3 VA facilities. No military distribution. Foreign accounts in Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Latvia, Libya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, New Zealand, Poland, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United Arab Emirates.
“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.
“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.
“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.
“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.