On December 15, 2016, Zimmer Biomet issued a Class 1 recall of its Comprehensive Reverse Shoulder System (Model 115340) over issues with the devices fracturing.
The Comprehensive Reverse Shoulder is a shoulder replacement device that is surgically implanted to help restore arm movement. This device is beneficial for patients with rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed shoulder joint replacement.
A Class 1 indication from the FDA indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The shoulder devices are being recalled by Zimmer Biomet because they are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
Zimmer Biomet is recalling a total of 3,662 devices.
They are identified as follows:
- Product Codes KWS and PAO;
- Part Number 115340;
- Manufactured between Aug. 25, 2008 and Sept. 27, 2011 and distributed between Oct. 2008 and Sept. 2015;
- See full list of lot numbers
If you or a family member received the Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340, you might be eligible for financial compensation.
Contact us today at (800) 351-8588 or click here to have a representative from our law firm contact you.