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Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8
Recalled November 29, 2017 · FDA recall Z-0115-2018 · Zimmer Biomet
Hazard
Potential for software to change the final tool orientation for the command position without command. · FDA Class II
Units
64 units
Sold at
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
Description
Potential for software to change the final tool orientation for the command position without command.
Product
ROSA Surgical Device 2.5.8
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →