Rosa Brain 3 — Class I medical device recall Z-0172-2020
Terminated recall by MEDTECH SAS, reported 2019-11-13, distributed nationwide. The instrument holder may be sent on a trajectory that is not within the intended target. If it is not correct
| Recall number | Z-0172-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDTECH SAS, Montpellier, N/A, France |
| Recall initiated | 2019-09-10 |
| Classified | 2019-11-01 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, FR, TW, VN |
| Quantity | 93 |
Product
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.
Reason for recall
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
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-0172-2020. 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.