FDA-Device2017-12-06Class II
ROSA Surgical Device 2.5.8
Zimmer Biomet, Inc.
Hazard
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Sold states
AR, OH, MI, and TX
Affected count
22 units (4 US and 18 OUS)
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-0178-2018Don't want to check this manually?
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