FDA Device recall Z-2868-2017
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 neu…
- FDA Device
- Class II
- terminated
- Published 2017-08-09
On 2017-08-09 the FDA classified a Class II recall of 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 neu… by Zimmer Biomet, citing complaint of the head holder connector locking up mechanically when tightened.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2868-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-11 |
| Published | 2017-08-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, DC, FL, MA, MN, NC, NY, OH, PA |
Product
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.
Reason
Complaint of the head holder connector locking up mechanically when tightened.
Identifiers
| code_info | Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014,…Device Listing No. D264591, Serial No. BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, BR16024. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2868-2017%22
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