MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France is recalling Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On September 10, 2019, the firm issued an Urgent Medical Device Correction to customers, advising them of the product issue. The customer notification included instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur. The firm stated that they would provide a label containing the workaround instructions that could be applied directly to the unit by September 30, 2019. A Zimmer Biomet engineer will be deployed to each customer site to implement a new software version to correct the issue. Customers will be contacted by 10/31/19 with additional information regarding this planned update and the estimated timing. For surgeons, there are no specific patient monitoring instructions related to this field action that are recommended beyond your existing follow-up schedule. If you have further questions or concerns after reviewing this notice, please call Perry Twyford at 281-389-3236 between 9:00 am and 6:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026