Class II — MEDTECH SAS
| Recalling firm | MEDTECH S.A.S |
|---|---|
| Registered facility | MEDTECH SAS (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Replacement of units lacking an updated device approval. |
| Product | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropr… |
| Quantity | 29 units |
| Distribution | US Distribution |
| Initiated | 2018-05-08 |
| Classified | 2018-06-07 |
| Terminated | 2020-08-19 |
| Recall number | Z-2108-2018 |
| 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 II recall — MEDTECH SAS (Z-2108-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80061/
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