Recall Z-0100-2018 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 | Apr 19, 2012 |
| Status | Terminated |
| Reason | Potential failure of the optical distance sensor due to cable disconnection. |
| Root cause | Device Design |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall Correction letter dated July 26, 2017, to all affected customers. Customers were informed on site of the device correction by Field Service Technicians. For questions regarding this recall call 574-267-6131. |
| Quantity | 14 units |
| Distribution | Worldwide Distribution - US including OH and MI Internationally to Canada, China, France, Germany, and Italy |
| FDA record | Open on fda.gov |