ROSA BRAIN 3 — Class II medical device recall Z-0116-2018
Terminated recall by Zimmer Biomet, Inc., reported 2017-11-29, distributed in OH, PA. Non-conforming product label.
| Recall number | Z-0116-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-07-29 |
| Classified | 2017-11-18 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2020-06-16 |
| Distributed | OH, PA |
| Quantity | 2 devices |
| Reason classes | labeling |
| Serial numbers | BR16017, BR16018 |
Product
ROSA BRAIN 3.0.0
Reason for recall
Non-conforming product label.
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-0116-2018. 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.