Mazor X robotic guidance system REF: TPL0059
FDA Recall Z-1122-2026 · Posted 2026-01-16
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Recalling FirmMazor Robotics Ltd
Recall StatusOpen, Classified
Product CodeOLO
Date Initiated2025-12-10
Product Quantity549 systems
Reason for Recall
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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