Mazor Robotics Ltd recalls 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 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.

• FDA enforcement recordOfficial FDA database entry for Z-1122-2026
• FDA 510(k) clearance · K230064The device's official FDA premarket clearance record
• FDA device classification · OLOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mazor Robotics LtdSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.