On Feb. 16, 2017, Zimmer Biomet initiated a Class I Recall of its popular Comprehensive Reverse Shoulder System due to an excessive number of fractures in the humeral tray component. Unlike traditional total shoulder arthroplasty systems, the Comprehensive Reverse Shoulder System swaps the humeral head (ball) and glenoid (cup) to the opposite sides of the glenohumeral joint in hopes of achieving greater range of motion in patients undergoing total shoulder arthroplasties. The humeral tray holds a polyethylene cup at the top of the humerus bone.
The recall is limited to joint systems containing 300 specific lot numbers distributed between October 2008 and September 2015, and encompasses approximately 3,600 of Zimmer Biomet’s shoulder systems. The recall states that patients who experience humeral tray fractures may need surgeries to revise the failed shoulder arthroplasty, and could suffer “permanent loss of shoulder function, infection or, rarely, death.” Zimmer Biomet began contacting patients who received the devices subject to the recall in late December.
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