FDA-Device2017-11-22Class II
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgic
Zimmer Biomet, Inc.
Hazard
Potential failure of the optical distance sensor due to cable disconnection.
Sold states
Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Affected count
14 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2018Don't want to check this manually?
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