Mazor Robotics Ltd — Mazor X robotic guidance system REF: TPL0059
⚠️ Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 10, 2025
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.
What's affected?
- Product
- Mazor X robotic guidance system REF: TPL0059
- Brand
- Mazor Robotics Ltd
- Lot code
- Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
Additional details
Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 549 systems.
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