Mazor X robotic guidance system REF: TPL0059
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 10, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | Mazor Robotics Ltd |
| Country / region | Israel 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. |
Hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Affected products
- Mazor X robotic guidance system REF: TPL0059
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