FDA Device recall Z-0638-2018
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device by Zimmer Biomet, citing robot arm being sent to the wrong position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0638-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-01 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, PA |
Product
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Reason
Robot arm being sent to the wrong position
Identifiers
| code_info | BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025. |
|---|
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-0638-2018%22
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