Mazor X robotic guidance system REF: TPL0059 recall (Mazor Robotics Ltd)

Medical deviceClass IIOngoing

Summary: Mazor Robotics Ltd is recalling Mazor X robotic guidance system REF: TPL0059. Reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

What is being recalled

Mazor X robotic guidance system REF: TPL0059

Why

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 named: Puerto Rico)

How to tell if yours is affected

Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Mazor Robotics Ltd · all medical device recalls · recalls from December 2025

Official FDA record