The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Recalled Product(s): ROSA Brain v3.0.0.0 and v3.0.0.5
- Product Codes: See a full list
- Manufacturing Dates: February 23, 2016 to December 21, 2018
- Distribution Dates: April 8, 2016 to March 19, 2019
- Devices Recalled in the U.S.: 86
- Date Initiated by Firm: September 10, 2019
Device Use
The ROSA Brain device is a robotic platform that assists neurosurgeons in positioning medical instruments or implants during surgery. The device is composed 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.
Reason for Recall
Zimmer Biomet recalled the ROSA Brain Device due to a software issue with ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported.
Who May be Affected
- Neurosurgeons and assisting medical personnel who use the ROSA Brain device in the operating room.
- Patients receiving neurosurgery during which the ROSA Brain device is used.