Zimmer Biomet has recently identified a rare software anomaly that can occur in ROSA Brain 3.0 robots. Specifically, when a particular sequence workflow is utilized, it results in a discrepancy between initial skin marking on the skull and instrument trajectory. In all cases, the issue was detected visually and/or through software prompts detected by the user and there have been no long-term adverse patient effects.
Importantly, the ROSA Brain 3.0 system software and specific surgical workflow is not deployed in other ROSA Brain, Spine or Knee devices. The ROSA Knee robot is built on a completely different software and hardware platform. ROSA Knee and ROSA One for Spine and Brain are not affected by this software anomaly.
Zimmer Biomet has notified ROSA Brain 3.0 users of a software recall to upgrade all units to the ROSA Brain 3.1, the current version of the robot. Until the unit upgrade is completed, users have been provided instructions to follow in order to address the anomaly. Therefore, while the updates are being implemented, Zimmer Biomet will work with surgeon users to ensure that there is no disruption to their ability to safely perform procedures on their patients. The Company has also self-reported the need for the ROSA Brain 3.0 unit upgrade to the FDA, and the FDA is expected to assign a classification to this software recall action in the near term.
Zimmer Biomet is dedicated to patient safety, and quality excellence is an integral aspect of our commitment to the patients and surgeons who rely on our products every day. We stand behind our products and we will reconfigure all of the ROSA Brain 3.0 units that are on the market today in a comprehensive and timely manner to ensure quality, safety and efficacy.