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 v188.8.131.52 and v184.108.40.206
- 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 v220.127.116.11 (v18.104.22.168 software) and ROSA Brain v22.214.171.124 (v126.96.36.199 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
BR16004 BR16005 BR16006 BR16009 BR16010 BR16011 BR16012 BR16013 BR16014 BR16015 BR16016 BR16017 BR16018 BR16021 BR16023 BR16025 BR17030 BR17034 BR17035 BR17036 BR17037 BR18024 BR18031 BR18038 BR18039 BR18040 BR18041 BR18042 BR18043 BR18045 BR18046 BR18047 BR18048 BR18049 BR18050 BR18051 BR18052 BR18053 BR18054 BR18055 BR18056 BR18057 BR18058 BR18059 BR18060 BR18061 BR18062 BR18063 BR18064 BR18065 BR18066 BR18067 BR18068 BR18069 BR18070 BR18071 BR18072 BR18073 BR18074 BR18075 BR18076 BR18077 BR18078 BR18079 BR18080 BR18081 BR18082 BR18083 BR18084 BR18085 BR18086 BR18087 BR18088 BR18089 BR18090 BR18091 BR18092 BR18093 BR18094 BR18095 BR18096 BR18097 BR18098 BR18099 BR18100 BR18101 BR15002 BR15003 BR16019 BR16028 BR16029 BR16026 BR16032
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.