Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
In what has become an alarming trend in drug and medical device manufacturing, Smith and Nephew felt compelled to copycat other hip implant manufacturers and market a pair of dual modular hip stems. This trend is alarming...more
The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more