Use cautionMedical device recall · FDA · Published September 10, 2019
Rosa Brain 3.0 Device Recall: Risk of Incorrect Placement During Neurosurgery
MEDTECH SAS recalls Rosa Brain 3.0 (Model ROSA 3.0) due to potential incorrect placement of surgical instruments during neurosurgery. The device is delivered assembled in a wooden case with plastic protection.
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.
Take action
Contact the company
📍Recalling firmMEDTECH SAS900 Rue Du Mas De Verchant · Montpellier, France
“Rosa Brain 3.0 Device Recall: Risk of Incorrect Placement During Neurosurgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67053-rosa-brain-3-0-device-recall-risk-of-incorrect-placement. Based on FDA recall #Z-0172-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0172-2020%22&limit=1).
The FDA announced on 2019-09-10 that MEDTECH SAS is recalling the Rosa Brain 3.0 surgical device due to a Class I hazard. The instrument holder may be sent on an unintended trajectory, potentially causing associated devices to be placed incorrectly.
According to the FDA, the instrument holder may be sent on a trajectory that is not within the intended target. If not corrected, the associated device may be placed incorrectly.
Context
GovInfoNow's records show MEDTECH SAS has issued three other recalls since 2018-05-08. Other recent recalls of similar products include Medicrea IB3D PL Instruments Set Recall (2025-10-29), Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (2026-07-09), and Mazor X Robotic System Software Errors Risk Incorrect Spinal Surgery (2025-12-10).
How to tell if you have this one
Check for the Rosa Brain 3.0 model (ROSA 3.0) delivered in a wooden case with plastic protection. The device is sold with specific model numbers listed in the recall notice.
Brand
MEDTECH SAS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify if your device has the model number ROSA 3.0 as listed in the recall notice.
Verify Device Condition
Ensure the device is delivered in a wooden case with plastic protection as described in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0172-2020 (September 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0172-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.