The FDA recently issued a class I recall for the Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray (Model 115340).
According to a medical device recall issued in February by the FDA, the system has a higher fracture rate than stated in the labeling. A class I recall is the FDA’s most serious recall category and indicates a device may cause serious injuries or death.
Zimmer Biomet sent out an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form on Dec. 20, 2016 to all the customers affected. A total of 3,662 devices were reportedly recalled. Those affected by the recall include health care providers who used the device for reverse shoulder replacement surgeries and patients who underwent total shoulder replacement with the device.