FDA MedWatch - ROSA One 3.1 Brain Application by Zimmer Biomet:

Class I Recall - Due to Error in Software

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: ROSA One 3.1 Brain Application by Zimmer Biomet: Class I Recall - Due to Error in Software AUDIENCE: Patient, Health Professional, Risk Manager, Neurology ISSUE: 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. RECOMMENDATIONS: 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. 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.  Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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