Lessons Learned from the Exactech Recall: How We Can Improve Medical Device Safety in the Future

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 2021—the FDA sent a Warning Letter to Exactech on March 12, 2024 informing the company that its manufacturing, packaging, storage and/or installation methods still present risks for patient harm……
By: Searcy Denney Scarola Barnhart & Shipley