Recall Z-2868-2017 ยท HAW Neurological Stereotaxic Instrument
Zimmer Biomet, Inc.
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may be appropriate.
| Date | Oct 11, 2016 |
| Status | Terminated |
| Reason | Complaint of the head holder connector locking up mechanically when tightened. |
| Root cause | Process design |
| Action | Product was/will be corrected by Field Technician staff in the form of a visit. |
| Quantity | 20 units (16 US, 4 OUS) |
| Distribution | Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151359 | ROSA Brain Medtech S.A, Dec 18, 2015 |