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(s): ROSA Brain v126.96.36.199 and v188.8.131.52
- 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
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 v184.108.40.206 (v220.127.116.11 software) and ROSA Brain v18.104.22.168 (v22.214.171.124 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.
What to Do
On September 10, 2019, Zimmer Biomet issued an Urgent Medical Device Correction to customers, advising them of the product issue, recommendations, and next steps:
- Customers should refer to the Urgent Device Correction letter for instructions for a workaround for the issue. Customers were also advised of the workflow that would cause the problem to occur.
- Zimmer Biomet stated that they would provide a label containing the workaround instructions that could be applied directly to the unit by September 30, 2019.
- A Zimmer Biomet engineer will be deployed to each customer site to implement software version 3.1 to correct the issue.
- Zimmer committed to contacting customers by October 31, 2019 with additional information regarding this planned update and the estimated timing.
Customers who have questions or concerns regarding this recall, may contact Perry Twyford at 281-389-3236 between 9:00 am and 6:00pm EST - Monday through Friday. Questions may also be emailed to CorporateQuality.PostMarket@zimmerbiomet.com
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How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX to 1-800-FDA-0178.