Mazor X robotic guidance system recall: Software Issue
Mazor X robotic guidance system REF: TPL0059
Why was Mazor X robotic guidance system recalled?
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are 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
- Product
- Mazor X robotic guidance system REF: TPL0059
- Recalling firm
- Mazor Robotics Ltd
- Quantity
- 549 systems
- 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.
- Recall date
- January 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)