Mazor X robotic guidance system REF: TPL0059

FDA device recall Z-1122-2026 · posted 2026-01-16 · Open, Classified

Recall details

Recalling firm

Mazor Robotics Ltd

Reason for recall

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OLO

Quantity affected

549 systems

Distribution

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, Ita

Date initiated

2025-12-10

Date posted

2026-01-16

Location

Caesarea, Israel

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