ROSA One 3.1 Brain application
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Recall Date: Sep 22, 2021
Recall ID: 88746
Product ID: 189497
Enforcement Date: Nov 3, 2021
Last Published: Oct 25, 2021
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Emert Number: Z-0118-2022
Emert Status: Notified