Serious shoulder problems have caused many to have to have replacement shoulder surgery.
Unfortunately, Zimmer Biomet Comprehensive Reverse Shoulder System is being recalled because of the high fracture rate.
On February 16, 2017, the FDA issued a Class I medical device recall on the model number 11530 due to serious complications, including infection, injury and even death.
The device recalled because when the device fractures, any nearby tissue or bone can experience damage when the comprehensive shoulder system moves. Some patients who experience major problems may require another surgery, while others simply aren’t able to handle the suggested surgery.
During one of these surgeries, the device may need to be completely removed, repaired or replaced.
See your doctor immediately if you or a loved one have had shoulder surgery for this defective medical device.