Class I — MEDTECH SAS
| Recalling firm | MEDTECH S.A.S |
|---|---|
| Registered facility | MEDTECH SAS (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 93 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam. |
| Initiated | 2019-09-10 |
| Classified | 2019-11-01 |
| Terminated | 2021-11-02 |
| Recall number | Z-0172-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — MEDTECH SAS (Z-0172-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83665/
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