Recall Z-0160-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
| Date | Nov 6, 2014 |
| Status | Terminated |
| Reason | Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended). |
| Root cause | Device Design |
| Action | All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites. |
| Quantity | 31 units |
| Distribution | US distribution in AR, GA, OH, MI, and TX. |
| FDA record | Open on fda.gov |