Medical Device Recall: Mazor X robotic guidance system REF: TPL0059
Mazor Robotics Ltd · December 10, 2025
Reason for Recall
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
549 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1122-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.