ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. ...
FDA Recall #Z-0096-2018 — Class II — December 18, 2013
Product Description
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
Reason for Recall
Possible break in the connector of the Force Sensor.
Recalling Firm
Zimmer Biomet, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21 units total
Distribution
Nationwide Distribution to OH, MI, and TX
Code Information
Model Number: ROSA 2.5.8
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated