UPDATE: Nov. 7, 2019: FDA slapped a Class I label on a Zimmer Biomet recall related to a software issue that jeopardizes the robotic arm positioning of the Rosa Brain system, a robot-assisted neurosurgery platform.
FDA said it is aware of five complaints related to the issue and one patient injury; no related deaths have been reported. A Class I categorization from FDA means regulators think using the devices could lead to injury or death.
The recall involves 86 devices distributed in the U.S. between April 2016 and March 2019, manufactured between February 2016 and December 2019. Affected device versions range between Rosa Brain v22.214.171.124 and v126.96.36.199.
- Zimmer Biomet said it has notified customers using its Rosa Brain 3.0 robots of a software recall to upgrade all units due to an anomaly that can cause a discrepancy between initial skin marking on the skull and the trajectory of the instrument.
- The statement from the orthopaedic device maker said the issue was detected visually or through software prompts in all cases, and there have been no long-term adverse effects on patients.
- The anomaly is rare and occurs when a particular sequence workflow is used, the company said.
Zimmer Biomet said the Rosa Brain 3.0 system software is not used in other Rosa Brain, Spine or Knee devices, and said they are not affected by the software issue.
The company said it notified FDA of the need for the Rosa Brain 3.0 upgrade, and expects the agency to soon classify the software recall. "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," the company said.
The company said it has distributed directions to surgeons it says will "address the anomaly" until a software upgrade is implemented in an effort to avoid disruptions to planned surgeries. With the software recall, Zimmer Biomet said it would upgrade Rosa Brain 3.0 robots to Rosa Brain 3.1, the current version of the robot.
Rosa Brain, Rosa Spine and Rosa One have been the subject of voluntary field actions due to software issues before. In 2017, the company informed surgeons of an issue, identified internally, in which the robot's arm may not reach its desired position when automatically sent to a trajectory because of an imperfect mathematical model.
The Rosa platform is an important device for Zimmer Biomet which hopes to catch up with rival Stryker and its Mako platform in the market for robot-assisted knee surgeries. In July, Zimmer Biomet said the company is gearing up to boost investments in robotics research and development in the second half of this year. An early 2020 launch is set for its Rosa Spine device.
Separately, Zimmer Biomet on Monday announced it received FDA 510(k) clearance for its JuggerStitch next-generation meniscal repair technology.