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Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be us
Recalled November 22, 2017 · FDA recall Z-0100-2018 · Zimmer Biomet
Hazard
Potential failure of the optical distance sensor due to cable disconnection. · FDA Class II
Units
14 units
Sold at
Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy
Description
Potential failure of the optical distance sensor due to cable disconnection.
Product
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
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →