Recall Z-0105-2018 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be inappropriate.
| Date | May 27, 2016 |
| Status | Terminated |
| Reason | Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device. |
| Root cause | Process control |
| Action | Zimmer Biomet Field Service Technicians replaced Field Locking Systems on site. |
| Quantity | 3 units |
| Distribution | Worldwide Distribution - US (DC) and Internationally to Australia and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101791 | ROSA SURGICAL DEVICE Medtech S.A.S, Sep 23, 2010 |