Recall Z-0099-2018 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
| Date | Feb 5, 2013 |
| Status | Terminated |
| Reason | Observed instability of the device. |
| Root cause | Device Design |
| Action | Zimmer Bioment notified consignees of the recall by visits from Field Service Technicians of the recalling firm looking to correct the device issue. For questions regarding this recall call 574-267-6131. |
| Quantity | 53 units |
| Distribution | Nationwide Distribution to AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, NY, OH, PA, and TX |
| FDA record | Open on fda.gov |