Zimmer Biomet is a medical device company founded in 1927. Recently, it has come under scrutiny after the U.S. Food and Drug Administration (FDA) announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implants. Class I recalls are the most serious types the agency can issue, involving defective devices that could cause serious injury or death.
These devices were recalled because of a high fracture rate that wasn’t stated in the labeling. Fractures that result could lead to revision surgeries, which could cause serious health consequences, such as permanent loss of shoulder function, infection, or death.
The company issued the recall in December 2016, but all patients who received the implant might not have been informed of the company’s action. The devices were manufactured between Augusts 2008 and September 2011 and were distributed from October 2008 to September 2015.
Part of the reason for this error was that the clearance for the device was received through the 510(K) process, which is expedited. Certain medical devices can go to market without regular safety testing when the device maker can demonstrate that the new device is similar enough to an already approved device.
If you or a loved one received the implant anytime from 2008 to 2016 and have experienced serious complications, talk to us as soon as possible, Shaheen & Gordon is currently filing lawsuits for the design, manufacture, and marketing of defective medical devices. Make sure you get the compensation you deserve. Fill out our online form to tell us about your situation.