Recall Z-0184-2018 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 us
| Date | Sep 5, 2014 |
| Status | Terminated |
| Reason | The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. |
| Root cause | Software design |
| Action | This is a retrospective report of a correction initiated on 05-Sept-2014. The software issue described was corrected in the modification to the MXTTOUT controller parameter settings. There were 8 affected devices at customer sites in the US. Field Service Technicians were deployed to the consignee locations to perform the system upgrade. |
| Quantity | 29 (8 US and 21 OUS) |
| Distribution | Nationwide Distribution to AK, OH, TX, GA, and MI |
| FDA record | Open on fda.gov |