FDA-Device2017-11-22Class II
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Zimmer Biomet, Inc.
Hazard
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Sold states
OH, MI and TX
Affected count
21 (4 US and 17 OUS)
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2018Don't want to check this manually?
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