FDA Issues a Class I Recall of the ROSA Brain 3.0 Robotic Surgery System by Zimmer Biomet
Medical device company Zimmer Biomet recently issued a Class I recall of the ROSA Brain 3.0 Robotic Surgery System due to a major software issue that caused the device to malfunction. The malfunction could cause serious injury or even death to patients receiving neurosurgery that utilizes the device. Here, the medical product liability attorneys at Peter Angelos, P.C. detail the Class I recall and who may be affected by the defective device.
What is the ROSA Brain Device?
The ROSA Brain Device, which is composed of a robotic arm and a touch screen system, is a medical device that select neurosurgeons use during surgical procedures. The devices aid in positioning medical instruments during surgery. It can also assist surgeons during implant surgery and can hold various attachments depending on the type of procedure it is being used for.
Why was the ROSA Brain Device Recalled?
The ROSA Brain Device was recalled due to a defect that may cause the device to malfunction. Specifically, the robotic arm could potentially move to the incorrect position, causing significant and preventable harm to the individual receiving the surgery. The FDA has labeled the recall a Class I recall, which is the most significant type of recall that can be issued. The recalled products, the ROSA Brain v220.127.116.11 and ROSA Brain v18.104.22.168, were manufactured between February 2016 and December 2018. The recall, which was issued on September 10th, 2019, included 86 ROSA Brain Devices in the United States. While no deaths have been reported as of yet, medical device company Zimmer Biomet has received five complaints related to the software issue, including one patient who was injured as a result of the defect.
Who May Be Affected by the Defective Device and Recall?
The defective ROSA Brain Device and subsequent recall can potentially impact many patients and medical health professionals. Neurosurgeons rely on the safety and accuracy of the ROSA Brain Device when performing surgery, and these surgeons can be drastically affected by a defective device that results in serious and even deadly complications. In addition, patients receiving surgery could suffer avoidable injury or death if they receive surgery that utilizes a defective robotic device such as the ROSA Brain Device. It is critical for medical personnel to be equipped with updated and effective surgical devices to ensure a safe and successful operation, and patients requiring serious neurosurgery who place their trust in the hands of the medical industry should feel confident in the efficacy of the medical devices being utilized to perform their surgery.
Discuss Your Legal Options with the Medical Device Liability Professionals at Peter Angelos, P.C.
The Class I recall of Zimmer Biomet’s ROSA Brain 3.1 Robotic Surgery System is a serious issue could potentially impact a host of medical professionals and patients. Medical product manufacturers such as Zimmer Biomet have the utmost duty to ensure their medical devices are effective, accurate and free from any defects or possibility of malfunction. To read the full FDA report regarding the issue, click here. If you or a loved one was injured as a result of the defective ROSA Brain Devices, contact Peter Angelos, P.C. immediately.