Company:Zimmer Biomet, Inc
Date of Enforcement Report 12/6/2017
Class lI:
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.
Recall Number Z-0184-2018
REASON
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 9/5/2014. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
29 (8 US and 21 OUS)
DISTRIBUTION
Nationwide Distribution to AK, OH, TX, GA, and MI
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