FDA-Device2017-11-29Class II
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Zimmer Biomet, Inc.
Hazard
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Sold states
US distribution in AR, GA, OH, MI, and TX.
Affected count
31 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2018Don't want to check this manually?
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