Recall Z-0116-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA BRAIN 3.0.0
| Date | Jul 29, 2016 |
| Status | Terminated |
| Reason | Non-conforming product label. |
| Root cause | Error in labeling |
| Action | All affected devices received a corrected label. Correction notification and implementation were performed by field technicians. |
| Quantity | 2 devices |
| Distribution | OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151359 | ROSA Brain Medtech S.A, Dec 18, 2015 |