FDA Device recall Z-0116-2018
ROSA BRAIN 3.0.0
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of ROSA BRAIN 3.0.0 by Zimmer Biomet, citing non-conforming product label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0116-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-29 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | OH, PA |
Product
ROSA BRAIN 3.0.0
Reason
Non-conforming product label.
Identifiers
| code_info | Serial No. BR16017 and BR16018 |
|---|
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-0116-2018%22
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