Z-1122-2026Class II

Mazor X robotic guidance system REF: TPL0059

Name: Z-1122-2026 Mazor X robotic guidance system REF: TPL0059
Creator: Mazor Robotics Ltd
Published: 2025-12-10
License: https://open.fda.gov/license/

Mazor Robotics Ltd / initiated 2025-12-10 / Open, Classified / root cause: software

FDA source

Mazor Robotics Ltd began a recall of Mazor X robotic guidance system REF: TPL0059 on 2025-12-10. FDA classified it as Class II and gives the reason as "Software errors that can result in incorrect surgical instrument positioning during spinal surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1122-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-10
Posted: 2026-01-16
Recalling firm: Mazor Robotics Ltd
Product: Mazor X robotic guidance system REF: TPL0059
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Root cause tag: software
FDA 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 [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.
Quantity in commerce: 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, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.
Product codes and lots: Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-16

Product code OLO

K230064Class IIMazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd. / cleared 2023-04-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)