The US Food and Drug Administration (FDA) has identified the recall of Zimmer Biomet’s ROSA One 3.1 Brain Application as Class I, the most serious among the three levels.
The move comes after Zimmer Biomet issued a recall for the platform, citing software issues.
The ROSA One 3.1 Brain Application is designed to help neurosurgeons perform surgeries on patients by accurately positioning medical instruments or implants.
The system includes a compact robotic arm as well as a touch screen for input. Other instruments or tools, such as biopsy needles, stimulation or recording electrodes, and endoscopes, can be attached to the end of the robotic arm to support the surgical procedure.
According to the FDA, Zimmer Biomet issued the recall of the robotic platform following the detection of a software anomaly that could hinder the accurate placement of instruments, which in turn could lead to serious injuries and even death.
There have been three global complaints related to the issue. However, there are no reports of patient injuries or death.
Zimmer Biomet had said that the ROSA Spine, Total Knee, Partial Knee and Hip application systems are not affected by the software error.
The company has recalled the devices distributed between 1 December 2019 and 31 August 2021. In the US, a total of 119 devices have been recalled.
The FDA said that the recall will impact health care providers using the affected ROSA One 3.1 Brain Application as well as patients who have procedures scheduled that would have used the application.
Earlier in the year, Zimmer Biomet and Canary Medical’s smart knee implant received clearance from the FDA.