FDA Medical devices recall ·
Mazor X robotic guidance system recall
- Recall number
- Z-1122-2026
- Date
- (initiated December 10, 2025)
- Company / brand
- Mazor Robotics Ltd
North Industrial Park, Caesarea, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 549 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Mazor X robotic guidance system REF: TPL0059
Why was it recalled?
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
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.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1122-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.