Company: Zimmer Biomet
Date of Enforcement Report: 10/29/2021
Class I
PRODUCT
ROSA One 3.1 Brain Application:
The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with 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 or tools (for example, biopsy needles, stimulation or recording electrodes, endoscopes) may be attached to the end of the robotic arm, depending on the surgical procedure.
Recall Number: NA
REASON
Zimmer Biomet is recalling this product due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures (for example, techniques to direct the tip of a tool using coordinates provided by medical imaging to reach a specific part of the brain). If this occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death.
There have been three complaints about this device issue. There have been no deaths or injuries reported about this device issue.
RECALLING FIRM/MANUFACTURER
Zimmer Biomet on 9/22/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
119
DISTRIBUTION
U.S. Nationwide and International