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 recallsāwhich began in 2021āthe FDA sent a Warning Letter to Exactech on March 12, 2024 informing the company that its …