Zimmer Biomet Initiates Recall of Comprehensive Reverse Shoulder System Device Due to Fracturing
The U.S. Food and Drug Administration (FDA) recently announced a Class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System, Model 115340 (“CRS”). A Class I recall is the highest level of recall according to the FDA’s regulations. This class of recall is used in situations in which there is a reasonable probability that using the subject product or exposure to the subject product will cause adverse health consequences or even death. Zimmer Biomet initiated the recall after reports indicated that the CRS device fractures at a higher rate than indicated on the label.
The CRS device is a shoulder replacement mechanism that is implanted into eligible patients, and it is designed with the intention of restoring arm movement. Some of the most common patients who have received the CRS device in a surgical procedure are patients who experience a tear in their rotator cuff and who experience severe arthritis in their shoulder as a result. This level of arthritis is commonly referred to as arthropathy. The patients have also typically experienced a failed shoulder joint replacement procedure prior to receiving the CRS implant.
According to the recall announcement, physicians who have used the CRS device in shoulder replacement procedures are affected. The announcement encourages them to review the safety notice and other associated information regarding the CRS device, identify any remaining devices that have not yet been used in surgical procedures, and contact any patients who received the CRS device in a surgical procedure. Patients who received or believe they have received the CRS device should consult their physician immediately. Devices subject to the recall were manufactured between August 25, 2008 and September 27, 2011.
Individuals who experience a fracture in the device often require a revision surgery to correct the issue. In some cases, the fracture can lead to additional complications, such as infections, reduced shoulder mobility, a complete loss of shoulder function, or death.
If you have been injured as a result of a defective medical device, you can bring a strict product liability claim against the manufacturer to seek compensation for your injuries. The elements that a plaintiff must prove to prevail in a strict product liability claim vary from state to state. In general, the plaintiff must show that the defendant designed the device in an unreasonable manner, that the device suffered from a defect during the manufacturing process, or that the device failed to include appropriate warnings. A successful plaintiff is entitled to recover compensation for his or her medical expenses, lost wages, reduced earning capacity, and other expenses associated with the injury. In some jurisdictions, the plaintiff is also entitled to compensation for pain and suffering or diminished quality of life.
At Moll Law Group, our skilled team of dangerous medical device lawyers is actively investigating potential claims against Zimmer Biomet regarding the CRS device. Having represented victims across the United States, including in Illinois, California, Florida, and New York, we offer a free consultation to help you learn about your legal options. To schedule your appointment with a Biomet attorney, call us now at 312-462-1700 or contact us online to get started.
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