FDA-Device2026-01-28Class IIPROCESSING DEFECT
Mazor X robotic guidance system recalled for software positioning errors in spinal surgery
OTHERNationwide distribution
Check Mazor X robotic system software
Mazor Robotics has recalled its Mazor X robotic guidance system due to software errors in certain versions that could cause incorrect positioning of surgical instruments during spinal surgery. The affected software versions are 5.0.1, 5.1.2, and 5.1.3. About 549 systems worldwide are affected, and no injuries have been reported.
- If your facility uses a Mazor X system, contact Mazor Robotics immediately to verify your software version
- Do not use the system until you confirm your software is not version 5.0.1, 5.1.2, or 5.1.3
- Update to a corrected software version if available, or follow Mazor's instructions for remediation
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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