ROSA Brain 3 — Class II medical device recall Z-0105-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed in DC. Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
| Recall number | Z-0105-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-05-27 |
| Classified | 2017-11-17 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-06-16 |
| Distributed | DC |
| Countries outside the US | AU, FR |
| Quantity | 3 units |
| Serial numbers | BR15002, BR15003, BR16004 |
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 for recall
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
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-0105-2018. 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.