No long-term adverse events were reported from the problem, in which a sequence workflow can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory,” the Warsaw, Ind.-based company said.
“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,” the company said Sept. 13. The issue does not affect other Rosa robot-assisted systems for brain, spine and knee procedures. Zimmer acquired the Rosa line when it bought Montpellier, France-based Medtech in 2016.
An upgrade to Rosa Brain 3.1 is under way; in the meantime, Zimmer said it’s working with surgeons to address the anomaly “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,” the company said. “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.”