Recall Z-1122-2026 ยท OLO Orthopedic Stereotaxic Instrument
Mazor Robotics Ltd
Mazor X robotic guidance system REF: TPL0059
| Date | Jan 16, 2026 (initiated Dec 10, 2025) |
| Status | Open, Classified |
| Reason | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. |
| Root cause | Under Investigation by 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 neuro.quali |
| Quantity | 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, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovak |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230064 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., Apr 7, 2023 |