A Class 1 recall by the Food and Drug Administration (FDA) is the most serious type of recall issued by the FDA. Medical devices recalled in this manner may cause serious injury or death.
The FDA has recently announced a Class 1 recall of the Zimmer Biomet Comprehensive Reverse Shoulder. The product description is listed as the "Comprehensive Reverse Shoulder System Humeral Tray Model 115340." The affected product codes are KWS and PAO, with several lots of part number 115340. The device was distributed between Oct 2008 and September 2005, with manufacturing dates of Aug. 25, 2008 to Sept. 27, 2011. The recall affects 3,662 devices.