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.
MEDTECH SAS is recalling the Rosa Brain 3.0 device because it may not position surgical instruments correctly during neurosurgery. This could lead to improper tool placement if the device is not adjusted properly.
The instrument holder may move along an unintended path, causing the surgical device to be placed incorrectly. If this issue isn't corrected, it could lead to improper positioning of surgical tools during procedures.
Neurosurgeons who use the Rosa Brain 3.0 device for instrument positioning are most at risk. The recall affects devices sold with specific model numbers listed in the recall notice.
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.
Identify if your device has the model number ROSA 3.0 as listed in the recall notice.
Ensure the device is delivered in a wooden case with plastic protection as described in the recall.
The recall indicates a potential risk of incorrect placement during use, so it is recommended to check if your device is affected before continuing to use.
The affected model numbers are listed in the recall notice, including ROSA 3.0 and specific numbers like BR16004 through BR18101.
The recall does not specify a return or remedy, so no action is required beyond checking if your device is affected.
We’ve drafted a message you can send MEDTECH SAS to request your refund or repair — edit it as you like.
Subject: Recall Z-0172-2020 — MEDTECH SAS MEDTECH SAS Hello, I own a MEDTECH SAS that is covered by recall Z-0172-2020 from MEDTECH SAS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
