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The U.S. Food and Drug Administration (FDA) has announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder device. 

The Comprehensive Reverse Shoulder is a shoulder replacement device designed for patients with rotator cuff tears who have previously failed shoulder joint arthroplasty and have developed arthropathy. The manufacturer has received reports that the devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. Learn more...