Zimmer Biomet recalled its Rosa Brain 3.0 system due to a software problem that can drive the robotic arm to an incorrect position during brain surgery. The company initiated the recall back in September but FDA just flagged the recall on Thursday.
So far there have been five complaints related to the problem, including one patient injury, but no deaths have been reported.
Rosa Brain is a robotic platform designed to assist neurosurgeons in positioning medical instruments or implants during brain surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments may be attached to the end of the robotic arm depending on the procedure.
The company told FDA it would provide a label containing workaround instructions that can be applied directly to the robot. A Zimmer Biomet engineer is also being sent to each customer site to install updated software to correct the issue. Customers should have been contacted by Oct. 31 with information about the planned update and the estimated timing.