MEDTECH SAS
FDA Regulatory Profile
MEDTECH SAS has 5 FDA recalls (2 Class I), 5 inspections, 12 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0118-2022 · Class I · Sep 22, 2021
- Latest inspection
- Jul 24, 2025 · VAI
- Latest 510(k)
- Jul 20, 2023
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 (2 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 12 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0118-2022 | Class I | ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation… | Sep 22, 2021 |
| Z-1151-2020 | Class II | ROSA One 3.1 Brain Application | Jan 6, 2020 |
| Z-1150-2020 | Class II | ROSA Brain 3.0 Application-Brain | Jan 6, 2020 |
| Z-0172-2020 | Class I | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected… | Sep 10, 2019 |
| Z-2108-2018 | Class II | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a… | May 8, 2018 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 24, 2025 | Mauguio, France | Devices | Voluntary Action Indicated (VAI) | 3009185973 |
| Jun 30, 2022 | Millington, TN | Devices | Voluntary Action Indicated (VAI) | 3010123256 |
| Nov 16, 2017 | Mauguio, France | Devices | No Action Indicated (NAI) | 3009185973 |
| Apr 5, 2012 | Savannah, GA | Biologics | No Action Indicated (NAI) | 3006426878 |
| Nov 3, 2009 | Savannah, GA | Biologics | No Action Indicated (NAI) | 3006426878 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231103 | ROSA ONE Brain Application | Jul 20, 2023 |
| K214065 | ROSA ONE Brain application | May 4, 2022 |
| K200511 | ROSA ONE Brain application | May 29, 2020 |
| K192173 | ROSA ONE Spine application | Oct 29, 2019 |
| K182848 | ROSA ONE Spine application | Mar 22, 2019 |
| K182417 | ROSA ONE Brain Application | Feb 7, 2019 |
| K172444 | ROSA BRAIN (v3.0.0.5) | Mar 28, 2018 |
| K151511 | ROSA Spine | Jan 4, 2016 |
| K151359 | ROSA Brain | Dec 18, 2015 |
| K101791 | ROSA SURGICAL DEVICE | Sep 23, 2010 |
| K092239 | ROSA SURGICAL DEVICE, MODEL ROSA 1.1 | Nov 17, 2009 |
| K990663 | INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 | May 27, 1999 |