FDA recall, , Moderate risk
Mazor Robotics Mazor X Robotic Guidance System
The Mazor X robotic guidance system has software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Summary by Recall Canary from the FDA notice
What happened
Mazor Robotics Ltd, located in Caesarea, Israel, recalled the Mazor X robotic guidance system REF: TPL0059 because software errors can result in incorrect surgical instrument positioning during spinal surgery. The company began the recall on December 10, 2025, and the FDA added it to its Enforcement Report on January 16, 2026. The recall involves 549 systems distributed worldwide, including the United States and numerous other countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Mazor X robotic guidance system REF: TPL0059
- UDI-DI
- 07290109180465
- 07290109184524
- 07290109181158
- 00763000635169
- 07290109183213
- 07290109184517
- 00763000419134
- 00763000431761
- 07290109184098
- 07290109184838
- 07290115751376
- 07290115751895
Recall details
- Company began the recall
- Sold in
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.
- Company
- Mazor Robotics LtdCaesarea, Israel
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98199
- Recall number
- Z-1122-2026
- Quantity recalled
- 549 systems
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
