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 devices are being recalled because they have been found to be fracturing at a higher rate than stated in the labeling, according to the FDA. Fractures may require revision surgeries, which could cause permanent loss of shoulder function, infection or death, the Agency said.
The company is recalling a total of 3,662 devices with product codes KWS and PAO and part number 115340, manufactured between Aug. 25, 2008 and Sept. 27, 2011 and distributed between Oct., 2008 and Sept., 2015.
Zimmer-Biomet began sending recall notices for the devices on Dec. 20 last year with instructions for quarantining and returning affected devices.
Earlier this month, Zimmer-Biomet won CE Mark approval in the European Union for its for the Subchondroplasty procedure designed to treat subchondral bone marrow lesions.
The company’s minimally invasive procedure is designed to repair chronic BMLs includes filling them with AccuFill bone substitute material which is slowly resorbed and replaced with healthy bone.
The procedure is generally performed with arthroscopy for visualization and joint treatments, the company said, with an open or mini-open procedure necessary for certain cases.