Company:Zimmer Biomet, Inc
Date of Enforcement Report 11/29/2017
Class lI:
PRODUCT
ROSA Surgical Device 2.5.8.
Recall Number Z-0115-2018
REASON
Potential for software to change the final tool orientation for the command position without command.
RECALLING FIRM/MANUFACTURER
Zimmer Biomet, Inc.Warsaw, IN on 4/8/2016. Voluntary firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
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