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Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059
Recalled January 28, 2026 · FDA recall Z-1122-2026 · Mazor Robotics
Hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery. · FDA Class II
Units
549 systems
Sold at
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.
Description
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Product
Mazor X robotic guidance system REF: TPL0059
Manufacturer(s)
Mazor Robotics Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →