FDA-Device2026-01-28Class II
Mazor X robotic guidance system REF: TPL0059
Mazor Robotics Ltd
Hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.
Affected count
549 systems
Manufactured in
North Industrial Park, 5, Shakham, Caesarea, Israel
Products
Mazor X robotic guidance system REF: TPL0059
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1122-2026Don't want to check this manually?
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