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 to patients.

The FDA began warning of concerns related to Exactech’s Novation, AcuMatch, and MCS hip replacement devices in June 2021. Since then, the FDA has expanded its inquiry into Exactech’s manufacturing and packaging processes, and the Exactech recalls have expanded as well. To date, Exactech has published recalls through the FDA’s website not only for defective hip replacement devices, but for defective shoulder, knee and ankle replacement devices as well.

How and When the FDA Uses Medical Device Recalls to Protect Patients

Medical device recalls are far more common than they should be. Despite all of the federal laws and regulations that are in place to ensure that manufacturers don’t put dangerous medical devices on health care providers’ shelves, manufacturers don’t always follow the law.

To address this problem, the FDA issues recall notices as warranted. Depending on the nature of the issue with a particular medical device, the FDA will either issue a voluntary recall notice or institute a mandatory device recall. As the FDA explains:

“A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. . . .

“Medical device recalls are usually conducted voluntarily by the manufacturer . . . . In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer . . . .”

While Exactech has voluntarily recalled some of its defective medical devices, it has refused to voluntarily recall others. With regard to these devices, including Equinoxe Shoulder System Implants, the FDA is “continu[ing] to work with Exactech to evaluate the risks of all joint devices that contain plastic components packaged in defective packaging and review information they provide regarding their joint replacement devices’ safety and effectiveness.” However, on March 12, 2024, the FDA sent a Warning Letter to Exactech notifying the company that it has failed to take adequate corrective action to resolve the FDA’s ongoing concerns.

FDA investigations and medical device recalls can have various triggers. Oftentimes, and as was the case with Exactech, investigations and recalls flow from complaints submitted by patients and health care providers. Once the FDA uncovered issues with Exactech’s manufacturing and packaging processes with regard to its Novation, AcuMatch, and MCS hip replacement devices, the FDA then expanded its inquiry to assess any additional risks for patient harm from other dangerous Exactech implants.

Why the FDA Has Instituted Widespread Recalls for Exactech Devices

The FDA has issued widespread recalls for Exactech devices due to issues identified in the company’s manufacturing and packaging processes. Since these issues are not related to the design of particular implants but instead related to how the company manufactures and ships its implants to health care providers, the recalls are much broader than they would be with a device-specific issue. As the FDA explained last year:

“Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery.”

When the FDA conducted a follow-up inspection later in the year, it found that Exactech had failed to take adequate steps to remedy the problem. Specifically, the FDA found that Exactech’s “methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.” This led to the issuance of the Warning Letter referenced above—and it is a major reason why the FDA is still recommending against the implantation of any new Exactech ankle, knee, hip or shoulder replacement devices.

What It Means for Exactech Devices to Be Subject to an FDA “Class II” Recall

To date, all of the FDA’s Exactech device recalls have been classified as “Class II” recalls. This means that the FDA has determined, “use of, or exposure to, [Exactech’s devices] may cause temporary or medically reversible adverse health consequences or . . . the probability of serious adverse health consequences is remote.” To date, many patients have been forced to undergo revision surgery, and many patients have succeeded in recovering just compensation from Exactech for their medical expenses, pain and suffering, and other losses.

How to Find Out if Your Exactech Device Has Been Recalled

If you or someone you love has received an Exactech implant, you should find out if your (or your loved one’s) device is subject to a pending recall. To do this, the FDA recommends using Exactech’s Recall Serial Number Checker, which is available for free online. If you have your (or your loved one’s) device’s serial number, you can input it on Exactech’s website to find out if the device has been recalled. If you don’t have the serial number, your (or your loved one’s) health care provider should be able to provide it to you.

Schedule a Free Consultation with an Exactech Lawyer at Searcy Denney

If you need to know more about the FDA’s Exactech recalls, or if you have questions about filing an Exactech lawsuit, we invite you to get in touch. To schedule a free consultation with an Exactech lawyer at Searcy Denney, please call 800-780-8607 or inquire online today.