Recall Z-0096-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
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 u
| Date | Dec 18, 2013 |
| Status | Terminated |
| Reason | Possible break in the connector of the Force Sensor. |
| Root cause | Device Design |
| Action | Customers were informed onsite by Field Service Technicians of the planned correction. |
| Quantity | 21 units total |
| Distribution | Nationwide Distribution to OH, MI, and TX |
| FDA record | Open on fda.gov |