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U.S. Department of Health and Human Services

Class 2 Device Recall Mazor X System

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 Class 2 Device Recall Mazor X Systemsee related information
Date Initiated by FirmDecember 10, 2025
Date PostedJanuary 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1122-2026
Recall Event ID 98199
510(K)NumberK230064 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductMazor X robotic guidance system REF: TPL0059
Code Information Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
Recalling Firm/
Manufacturer		 Mazor Robotics Ltd
North Industrial Park
5, Shakham
Caesarea Israel
For Additional Information ContactMedtronic Customer Service
1800-9629888
Manufacturer Reason
for Recall		Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
FDA Determined
Cause 2		Under Investigation by firm
ActionBeginning 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 neuro.quality@medtronic.com. 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.
Quantity in Commerce549 systems
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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