The Role of the FDA in the Exactech Recall: A Critical Analysis

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 the U.S. Food and Drug Administration (FDA). The FDA is the federal agency responsible for ensuring the safety of medical devices sold in the United States, and it has the authority to conduct investigations and institute recalls when defective medical devices present risks…
By: Searcy Denney Scarola Barnhart & Shipley