The U.S. Food & Drug Administration (FDA) has announced a Class I medical device recall for Zimmer Biomet’s ROSA Brain 3.0 Robotic Surgery System.
According to a recall notice posted to the agency’s website on November 7th, a software issue could drive the system’s robotic arm to an incorrect position, creating risks for the patient.
The Zimmer Biomet ROSA Brain 3.0 Robotic Surgery System assists neurosurgeons in positioning medical instruments or implants during surgery. The system consists 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 to be completed.
A Class I recall is the FDA’s most serious class of recall, and indicates that use of a product may result in serious injury or death. Zimmer Biomet has apparently received five complaints related to the software issue, including one patient injury. So far, however, no deaths have been linked to the problem.
The recall includes the ROSA Brain Robotic Surgery System v184.108.40.206 (v220.127.116.11 software) and v18.104.22.168 (v22.214.171.124 software, collectively referred to as v3.0 software). The devices were manufactured between February 23, 2016, and December 21, 2018, and distributed between April 8, 2016, and March 19, 2019.
Zimmer Biomet sent affected customers a letter in September that included instructions for a workaround for the software issue. They were also advised of the workflow that would cause the problem to occur.
In addition, Zimmer Biomet provided a label containing the workaround instructions that could be applied directly to the robotic surgery system and was deploying an engineer to each customer site to implement software version 3.1 to correct the issue.
This is the second time this year the FDA has issued an alert relating to robotic surgery.
In February, the agency warned that the safety and effectiveness of robotic surgery systems have not been established for use in mastectomy procedures or the prevention or treatment of cancer. The FDA is currently monitoring adverse events to better understand the benefits and risks of robotically-assisted surgical devices when used for specific indications.
Patients considering robotic surgery for any reason should discuss the risk and benefits with their doctor before making a decision. In choosing a surgeon, they should also: