Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059
- Recalling company
- Mazor Robotics Ltd
- Product
- Mazor X robotic guidance system REF: TPL0059
- Reason
- Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 10, 2025
- Reported
- Jan 28, 2026
- 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.
- Status
- Ongoing
- Quantity
- 549 systems
- Lot / codes
- Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
- Company location
- Caesarea
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1122-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1122-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.