Mazor X robotic guidance system REF: TPL0059
Recall
- Recall Number
- Z-1122-2026
- Event Number
- 98199
- FEI Number
- 3005075696
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- December 10, 2025
- Posted
- January 16, 2026
- Address
- Mazor Robotics Ltd North Industrial Park 5, Shakham Caesarea Israel
Description
Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Beginning December 10, 2025, Medtronic (Mazor Robotics, Ltd) issued a Urgent Medical Device Recall Notification to affected consignees via E-Mail. Medtronic asked consignees to take the following actions: 1. Please review this information with all physician users and/or post a copy of this notification with your Mazor X system until the software update is completed. 2. Please confirm via the enclosed confirmation form that this notification has been communicated within your facility with all physician users. Send the completed Customer Confirmation Form to Medtronic via email at [email protected]. 3. Provide this notification to those who need to be aware within your organization or to any organization where the affected systems have been transferred. 4. Maintain a copy of this notice in your records. 5. Continue to use the Mazor X system as instructed in the user manual and with the mitigations provided below in Appendix A.
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.
549 systems