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 

  • ROSA One 3.1 Brain Application
  • Product Codes and Lot Numbers: See Recall Database Entry 
  • Devices Recalled in the United States: 119
  • Distribution Date: December 1, 2019 to August 31, 2021
  • Date Initiated by Firm: September 22, 2021

Device Use

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. 

Reason for Recall  

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. 

Who May Be Affected 

  • Health care providers using the affected ROSA One 3.1 Brain Application.
  • Patients who have procedures with the affected ROSA One 3.1 Brain Application.

What to Do 

On September 22, 2021, Zimmer Biomet sent an “URGENT MEDICAL DEVICE CORRECTION" requesting: 

Hospital staff: 

  • Review the “URGENT MEDICAL DEVICE CORRECTION" letter and ensure affected personnel are aware of the contents. 
  • Review the “Attachment 2 – Detailed Sequence of Events” attached to the “URGENT MEDICAL DEVICE CORRECTION" letter for the full sequence of events leading to the issue. 
  • Attach a Laminated Warning label to the robot as instructed by “Attachment 3 – Instructions for Applying the Warning Label” attached to the “URGENT MEDICAL DEVICE CORRECTION" letter.
  • Complete “Attachment 1 – Certificate of Acknowledgement” attached to the “URGENT MEDICAL DEVICE CORRECTION" letter and send to CorporateQuality.PostMarket@zimmerbiomet.com. 
  • Retain a copy of the Certificate of Acknowledgement form with your records in the event of a compliance audit of your facility’s documentation. 
  • Contact your Zimmer Biomet representative if you have further questions or concerns after reviewing this notice. 

Surgeons: 

  • Review the “URGENT MEDICAL DEVICE CORRECTION” letter for awareness of the contents. 
  • Review the “Attachment 2 – Detailed Sequence of Events” attached to the “URGENT MEDICAL DEVICE CORRECTION" letter for the full sequence of events leading to the issue.  
    • Check if there are no specific patient monitoring instructions related to the “URGENT MEDICAL DEVICE CORRECTION” letter that are recommended beyond your existing follow up schedule. 
  • Complete “Attachment 1 – Certificate of Acknowledgement” attached to the “URGENT MEDICAL DEVICE CORRECTION" letter and send to CorporateQuality.PostMarket@zimmerbiomet.com. 
  • Retain a copy of the Certificate of Acknowledgement with your records in the event of a compliance audit of your facility’s documentation.  
  • Contact your Zimmer Biomet representative if you have further questions or concerns after reviewing this notice. 

Contact Information 

Customers who have questions about this recall should contact their Zimmer Biomet representative or customer service by email at Medtech-CHT@zimmerbiomet.com or by phone at (574) 373-5097.

Additional Resources: 

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.