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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 December 6, 2017 · FDA recall Z-0184-2018 · Zimmer Biomet
Hazard
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. · FDA Class II
Units
29 (8 US and 21 OUS)
Sold at
Nationwide Distribution to AK, OH, TX, GA, and MI
Description
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
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 →