Z-1122-2026 Class II Ongoing
FDA device recall Z-1122-2026 was initiated by Mazor Robotics Ltd on Dec 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
- Jan 28, 2026
- Initiation Date
- Dec 10, 2025
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1122-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026