On February 16, 2017, the U.S. Food and Drug Administration (FDA) announced a Class I recall of Zimmer Biomet Comprehensive Reverse Shoulder implants. A Class I recall is the most serious type of recall the agency issues, and involves defective devices that can cause serious injury or death. 3,662 units are recalled. The shoulder implants were recalled because of a high fracture rate. If the device fractures, dangerous revision surgery is required and can result in permanent loss of use of the shoulder or even death.
Zimmer Biomet initiated the recall in December, 2016, sending an Urgent Medical Device Recall Notice to its customers. However, patients who received the shoulder implant may not have been informed of the recall.
According to the FDA announcement, the recalled devices were manufactured between August 25, 2008 and September 27, 2011. They were distributed from October, 2008 to September 2015. The recalled devices are called Comprehensive Reverse Shoulder System Humeral Tray Model 115340.
In 2008, Zimmer Biomet received clearance for the device through the controversial 510(K) process. It is an expedited clearance process that allows medical devices to go to market without the normal safety testing when the device maker can show that the new device is substantially similar to an already approved device.
If You have had Shoulder Replacement
If you have had shoulder replacement surgery, you may not know if your device has been affected by a recall. If you have a recalled Zimmer Biomet shoulder implant that has not yet failed, it is subject to fail in the future, causing serious injuries. You may be able to recover substantial compensation for your injuries, including medical expenses, lost income and pain and suffering.
If you have been harmed by shoulder replacement, please talk to an experienced defective medical device attorney right away to learn more about your rights and potential compensation.