The FDA this week issued a Class I recall for select Brainlab Spine & Trauma 3D navigation software products over a potential to display incorrect information during surgery that may affect the procedure.
Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The Brainlab Spine & Trauma 3D navigation software is designed for use with the Brainlab Spine & Trauma navigation system to provide patient images to aid surgeons safely navigate surgical tools and implants used before and during minimally invasive surgical procedures.
The FDA said that Brainlab issued the recall due to the potential that the software may display incorrect information during surgery that could prevent the surgeon from accurately navigating surgical tools inside the patient.
The federal watchdog said that incorrectly displayed data could result in damage to the patient’s body, a second, otherwise unnecessary, surgical procedure or serious life-threatening patient injuries or death.
The recall affects approximately 60 Brainlab Spine & Trauma 3D Navigation 1.0 programs in the US with product code HAW, manufactured and distributed between May 2018 and February 2019, according to the FDA release.
Brainlab began notifying users of the software on March 1, and provided instructions to reduce the risk of having incorrect data displayed on the system.
Last month, Smith & Nephew (NYSE:SNN) acquired Brainlab’s orthopedic joint reconstruction business and teased the unveiling of a next-generation surgical robotics platform for later this year.