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

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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. This is a very unfortunate scenario, and it is a scenario that has forced patients across the country to undergo revision surgery in order to mitigate their risk of long-term complications from defective Exactech devices.

It is also a scenario that has forced many patients (and families) to take legal action. When companies like Exactech manufacture and sell defective medical devices, they can—and should—be held accountable. While the Exactech recalls have provided many lessons learned for medical device manufacturers and the FDA, these insights do nothing to help those who have already suffered significant harm.

Understanding the Issues that Led to the Exactech Ankle, Knee, Hip and Shoulder Replacement Device Recalls

In many cases, medical device recalls involve issues with the way the device is designed. For example, a joint replacement device may cause pain or restricted mobility due to its design, or the materials chosen to manufacture the device may be prone to cracking under pressure or degrading over time.

But, with Exactech’s recalled medical implant devices, this isn’t the case—at least not primarily.

Instead, the majority of the issues with Exactech’s recalled devices have to do with the way these devices are manufactured and packaged. As a result, the issues don’t relate to a single specific type of Exactech implant, but instead to a substantial portion of Exactech’s entire product line. Regardless of whether Exactech’s implants have been properly designed (which may or may not be the case), issues later in the manufacturing and distribution processes have the potential to make them unsafe for implantation and long-term use. As the FDA explains:

“All Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers as indicated in the package specification. The recalled devices were packaged in defective bags that were missing one of the oxygen barrier layers that protect devices from oxidation.

“Defective bags may allow oxygen from the air to contact the plastic (polyethylene) component before it is implanted into a person’s body. If a large amount of oxygen contacts the plastic component before the device is implanted, it may lead to oxidation of the plastic component over time . . . .”

The FDA began identifying concerns with Exactech’s manufacturing and packaging processes at least as early as 2021—and this is when the first Exactech recalls took place. However, as noted above, nearly three years later, Exactech has failed to take corrective action—or even identify the corrective actions needed according to the FDA.

5 Ways to Improve Medical Device Safety in the Future

So, what are the lessons to be learned from the Exactech recalls? Here are some ways that medical device manufacturers, the FDA, and even patients and their families can help to improve medical device safety in the future:

1. Medical Device Companies Must Focus On All Stages of the Manufacturing Process

Beyond ensuring that the design of their implantable medical devices is safe, medical device companies must focus on safety at all stages of the manufacturing process. Even if a medical device has been designed properly, it can still present significant risks if it is not manufactured or packaged appropriately. Flaws in Exactech’s practices and procedures at these later stages are responsible for the hundreds of thousands of defective devices the company has sold over the past 20 years.

2. Medical Device Companies Must Prioritize Compliance

One way medical device companies can ensure that their manufacturing practices and procedures are adequate is by prioritizing compliance. Federal laws and regulations impose extensive compliance obligations that are specifically intended to ensure that no dangerous or defective devices end up on health care providers’ shelves. As alleged by the FDA, Exactech committed multiple compliance failures that could—and should—have prevented the need for the company’s widespread recalls.

3. The FDA Must Be Proactive About Enforcing Compliance to Protect Patient Safety

Recognizing the companies don’t always do the right thing, the FDA must be proactive about enforcing compliance to protect patient safety. While the FDA began issuing voluntary recall notices to Exactech in 2021, it is still struggling to bring Exactech into compliance in 2024. While the FDA only has a certain amount of resources available, it must ensure that it is using these resources in the most efficient and most effective way possible.

4. Patient Safety Should Always Be the Primary Concern

For medical device companies and the FDA, patient safety should always be the primary concern. Companies should not prioritize profits over safety—and the FDA should not allow them to do so. Exactech’s defective medical implants have negatively impacted countless patients’ lives, and this should never have been the case.

5. Patients and Their Families Should Hold Defective Medical Device Manufacturers Accountable

Patients and families can do their part to promote medical device safety by holding defective medical device manufacturers accountable. By suing companies like Exactech, patients and families can give these companies a reason to ensure that they do not sell more defective devices in the future. Exactech is currently facing lawsuits from patients and families nationwide, and many more have grounds to seek just compensation.

Speak with an Exactech Lawyer at Searcy Denney for Free

Do you have a lawsuit against Exactech? If so, you may be entitled to significant financial compensation for your medical expenses, loss of earnings, pain and suffering, and other losses. To discuss your legal rights with an Exactech lawyer at Searcy Denney for free, call us at 800-780-8607 or request an appointment online today.

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Posted By: Bud Wilder