FDA Device recall Z-0105-2018
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to gui…
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to gui… by Zimmer Biomet, citing insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0105-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-27 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | DC |
Product
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.
Reason
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
Identifiers
| code_info | Serial No. BR16004, BR15002, and BR15003 |
|---|
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-0105-2018%22
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