Recall Z-0102-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
| Date | Feb 14, 2014 |
| Status | Terminated |
| Reason | An undetected shift between the information displayed in the navigation software and the actual patient anatomy |
| Root cause | Error in labeling |
| Action | There were 4 units imported into the US and all have been corrected. |
| Quantity | 21 (4 US and 17 OUS) |
| Distribution | OH, MI and TX |
| FDA record | Open on fda.gov |