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A Timeline of the Exactech Recall: How it Unfolded

02/23/2024
Product Defect
BY

Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important for you to learn about the ongoing recalls and ensure that you seek appropriate medical care as necessary. If you or a loved one needs medical care due to receiving a defective Exactech implant, you will want to speak with a lawyer about your legal rights as well.

The History of Exactech’s Defective Ankle, Knee, Hip and Shoulder Implant Devices

While the recalls involving Exactech’s defective ankle, knee, hip and shoulder implant devices did not begin until 2021, the issues with these devices date all the way back to 2004. This is when, as the U.S. Food and Drug Administration (FDA) discovered, Exactech began using packaging that allowed its devices to become compromised before being implanted in patients’ bodies. As the FDA explains:

 “Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags . . . 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. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.”

While this information from the FDA is specific to Exactech’s ankle, knee and hip implants, the FDA has raised similar concerns with the packaging used to ship the company’s Equinoxe Shoulder System joint replacement devices to hospitals around the country. As a result, if you or a loved one has received any type of medical implant manufactured by Exactech, you will want to consult with your (or your loved one’s) healthcare provider to determine if the implant poses a health risk.

Here is a timeline of the Exactech recalls initiated to date:

June 2021

Exactech issued a recall for its Novation, Acumatch, and MCS hip replacement devices in June 2021. The recall related specifically to the “GXL” liners used in these devices, which presented a risk for “Excessive and premature wear.” The FDA classified this as a Class II recall, which means the FDA has determined that “use of, or exposure to, [these devices] may cause temporary or medically reversible adverse health consequences or . . . the probability of serious adverse health consequences is remote.”

October 2021

Exactech issued a recall for its Optetrak, Logic, and Truliant knee replacement and Vantage total ankle replacement devices in October 2021. The FDA also classified this as a Class II recall.

February 2022

On February 7, 2022, Exactech issued an expanded recall for its Optetrak, Logic, and Truliant knee replacement and Vantage total ankle replacement devices. This recall related specifically to devices shipped in the company’s defective packaging. According to the FDA, “around 80% of the knee and ankle replacement devices manufactured since 2004 were packaged in defective bags.”

April 2022

On April 7, 2022, Exactech issued an updated Urgent Medical Device Correction notice advising healthcare providers to avoid implanting the company’s knee and ankle replacement devices shipped in defective packaging. The notice covered devices manufactured between January 2004 and August 2021.

August 2022

Exactech expanded its hip replacement device recall in August 2022 to include all devices with polyethylene components shipped in defective packaging. The FDA also classified this as a Class II recall on September 9, 2022.

June 2023

On June 30, 2023, Exactech issued a recall for its shoulder replacement device systems. Unlike the previous ankle, knee and hip recalls, this recall related not to the devices’ packaging but rather to issues with the devices themselves and the tools used to implant them during surgery. This was also a Class II recall.

January 2024

On January 16, 2024, the FDA announced that Exactech has refused to issue a recall related to the packaging used to ship its shoulder implant devices. This is despite the fact that, “[s]ome Equinoxe Shoulder Systems were packaged in defective bags that were missing one of the oxygen barrier layers that protect the devices from oxidation,” similar to the company’s ankle, knee and hip implants. Even though Exactech has not issued a recall specific to this issue, the FDA still recommends against implanting Exactech Shoulder Systems that may have been shipped in defective packaging.

Ongoing Concerns Related to Exactech’s Defective Medical Devices

Unfortunately, for many patients, the Exactech recalls came too late. According to the FDA, Exactech has been shipping implant devices to healthcare providers in defective packaging since at least 2004. Additionally, despite the FDA’s recommendations against implanting Exactech’s potentially dangerous devices, many healthcare providers continued to implant Exactech devices after the recalls were issued.

With this in mind, anyone who received an Exactech implant in 2004 or later should consult with their doctor about the risks they may be facing. As outlined by the FDA, these risks include:

  • Bone loss
  • Component fracture
  • Device failure
  • Early and excessive device wear
  • Pain
  • Swelling

In some cases, patients may simply need to monitor for signs of these risks. However, in other cases, revision surgery to remove and replace a defective Exactech device may be necessary.

As we said in the introduction, if you or a loved one has received a defective Exactech implant, you will want to speak with a lawyer about your legal rights. The financial and non-financial costs of these defective implants can be devastating for many patients and families. However, Exactech can—and should—be held accountable, and you can hire an experienced lawyer to help you assert your legal rights at no out-of-pocket cost.

Speak with an Exactech Lawyer at Search Denney for Free

Would you like to speak with an Exactech lawyer about your legal rights? If so, we invite you to get in touch. To schedule a free, no-obligation consultation at Searcy Denney, please call 800-780-8607 or tell us how we can help online today.

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