FDA designates recall of Zimmer Biomet’s robotic neurosurgery platform as Class 1

The FDA has classified Zimmer Biomet’s recall of a robotic platform for neurosurgeons as Class 1, the most serious type of recall.

According to an FDA press release, the recall of the platform (Rosa One 3.1 Brain Application) is due to a software error that may lead to incorrect instrument placement during neurosurgical procedures, which could result in serious injury, stroke, disability or death.

The platform is used to help neurosurgeons during surgery with medical instrument positioning and patient implants. It consists of a compact robotic arm and a touch screen mounted on a stand. The recall will primarily affect health care providers currently using the platform and patients with upcoming procedures with the affected platform, according to the press release.

The agency stated in the release that three complaints have been received, but no deaths or injuries have been reported.

According to the release, adverse reactions and quality problems caused by the software can be reported through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.