Mazor Robotics Ltd
FDA adverse event reports naming Mazor Robotics Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MAZOR ROBOTICS LTD.
- Total reports
- 1,206
- Deaths
- 6
- Injuries
- 213
- Malfunctions
- 987
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- TerminatedDevice Design
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
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