ROSA Brain 3 — Class II medical device recall Z-0167-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed nationwide. Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
| Recall number | Z-0167-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-07-20 |
| Classified | 2017-11-21 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-06-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, FR |
| Reason classes | software |
| Serial numbers | BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021 |
Product
ROSA Brain 3.0.0 Usage: 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 for recall
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0167-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.