FDA-Device2017-11-29Class II
ROSA Surgical Device 2.5.8
Zimmer Biomet, Inc.
Hazard
Potential for software to change the final tool orientation for the command position without command.
Sold states
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
Affected count
64 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Surgical Device 2.5.8
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0115-2018Don't want to check this manually?
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