Z-1122-2026 Class II Ongoing
FDA device recall Z-1122-2026 was initiated by Mazor Robotics Ltd on December 10, 2025 and is designated Class II. Reason for recall: Software errors that can result in incorrect surgical instrument positioning during spinal surgery. The recall status is ongoing. Affected quantity: 549 systems.
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2026
- Initiation Date
- December 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 549 systems
Product Description
Mazor X robotic guidance system REF: TPL0059
Reason for Recall
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Distribution Pattern
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.
Code Information
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895