Class I Recall for Zimmer Biomet ROSA One 3.1 Brain Application

November 2, 2021 – San Diego, CA.  Zimmer Biomet is a medical device company that has come under legal problems due to faulty or defective products.  This FDA Class I recall, the most serious type of recall, is another example of this.

On September 22, 2021 Zimmer Biomet sent an “URGENT MEDICAL DEVICE CORRECTION” that outlines what steps medical providers, hospitals and doctors do. These instructions are:

• 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. 

What is the ROSA One 3.1 Brain Application Device?

ROSA ® is Zimmer Biomet’s brand name line of robotic multi-application platform that is used in different robot assisted surgeries. The ROSA ONE^® Brain is used to assist surgeons in performing complex neurosurgical procedures.  It can be used in the following procedures including:  

• Stereo Electroencephalography (SEEG) 
• Deep Brain Stimulation (DBS)
•  Stereotactic Biopsy
• Ventricular Endoscopy
• Transnasal Endoscopy

What is the reason for the recall?

According to the FDA’s MedWatch website it states the following:

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. 

What Models or Product Lot Numbers are recalled?

Product: ROSA One 3.1 Brain application.

Serial Numbers:  US: BS16904 BS16905 BS16906 BS16909 BS16910 BS16911 BS16912 BS16913 BS16914 BS16915 BS16916 BS16917 BS16918 BS16921 BS16923 BS16925 BS17930 BS17934 BS17935 BS17936 BS17937 BS18900 BS18901 BS18924 BS18931 BS18938 BS18939 BS18940 BS18942 BS18943 BS18945 BS18946 BS18947 BS18948 BS18949 BS18950 BS18951 BS18952 BS18953 BS18954 BS18955 BS18956 BS18957 BS18958 BS18959 BS18960 BS18961 BS18962 BS18963 BS18964 BS18965 BS18966 BS18967 BS18968 BS18969 BS18970 BS18971 BS18972 BS18973 BS18974 BS18975 BS18976 BS18977 BS18979 BS18980 BS18981 BS18982 BS18983 BS18984 BS18985 BS18986 BS18987 BS18988 BS18989 BS18990 BS18991 BS18992 BS18993 BS18994 BS18995 BS18996 BS18997 BS18998 BS18999 BS19037 BS19038 BS19039 BS19040 BS19041 BS19043 BS19047 BS19049 BS19050 BS19052 BS19053 BS19054 BS19057 BS19058 BS19059 BS19060 BS19061 BS19065 BS20066 BS20067 BS20072 BS20073 BS20079 BS20080 BS20086 BS20092 BS20100 BS20103 BS20107 BS21112 BS21115 BS21121 BS21129 BS21137 BS21138  OUS:  BS15902 BS15903 BS16007 BS16919 BS16928 BS16929 BS17008 BS17010 BS17013 BS17021 BS17022 BS17023 BS18024 BS18026 BS18027 BS18028 BS18030 BS18031 BS19032 BS19033 BS19034 BS19035 BS19036 BS19042 BS19051 BS19056 BS19062 BS19064 BS20068 BS20069 BS20070 BS20071 BS20074 BS20075 BS20076 BS20077 BS20078 BS20082 BS20084 BS20085 BS20090 BS20095 BS20098 BS20099 BS20102 BS20105 BS20106 BS21108 BS21109 BS21114 BS21124 BS21128 BS21132 BS21133 BS21134

Manufacturer Reason for Recall:

“The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.”

Not the first time Zimmer Biomet has faced lawsuits.

In 2014 the company settled out of court to cover more than 2,800 medical device lawsuits from its M2a Magnum hip replacement product over allegations of causing numerous complications including metal poisoning, and parts breaking and migrating throughout the body.  They ended up paying victims $56 million. That figure equates to about $200,000 for each plaintiff.

 Source:

https://www.fda.gov/medical-devices/medical-device-recalls/zimmer-biomet-recalls-rosa-one-31-brain-application-due-error-software