Defective Shoulder Replacement Device Recalled; High Fracture Rate
Defective Shoulder Device Recalled
FDA RECALLS SHOULDER DEVICE
According to a U.S. Food & Drug Administration report, on February 16, 2017, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 because the defective devices are fracturing at a higher rate than stated in the labeling. The device fracture are resulting in revision surgeries which could cause serious adverse health consequences, such as permanent loss of shoulder function, infection, and even death.
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
OVER 3,000 DEFECTIVE BIOMET DEVICES INVOLVED
The 3,662 recalled devices were manufactured between August 25, 2008, and September 7, 2011, and distributed between October 2008 and September 2015. The trade name of the Comprehensive Reverse Shoulder System Humeral Tray Model 115340 is Biomet Comprehensive Reverse Shoulder Humeral. Recalled products carry the product codes KWS or PAO. Affected lot numbers include all lots with part number 115340.
See the FDA Safety Alert
See the Recall
If you believe you or a loved one suffered a fracture and/or required a revision surgery due to a defective Zimmer Biomet shoulder implants call us today. At the Wall Huntington Law Firm, we are dedicated to assisting victims of medical malpractice and defective devices. To learn more, or to schedule a free consultation, call us today at 316-265-6000 or contact us online.
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