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
- Recall Number
- Z-0172-2020
- Event Number
- 83665
- Firm
- MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France
- FEI Number
- 3009185973
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Software in the Use Environment
- Initiated
- September 10, 2019
- Posted
- November 1, 2019
- Terminated
- November 2, 2021
Description
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.
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.
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 [email protected].
Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam.
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