The FDA this week released information on a Class 1 recall of Zimmer Biomet‘s (NYSE:ZBH) Comprehensive Reverse Shoulder System over issues with the devices fracturing.
The Warsaw, Ind.-based company’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have developed artropathy and have failed shoulder joint replacements.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The Warsaw, Ind.-based company’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have developed artropathy and have failed shoulder joint replacements.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
