The Exactech Recall: A Quick Synopsis and Update on What You Need to Know

Searcy Denney Scarola Barnhart & Shipley

Searcy Denney Scarola Barnhart & Shipley

Exactech is a medical device company that manufactures implantable joint replacements. It is also a company that has faced numerous lawsuits related to its products in recent years. In many cases, Exactech has acknowledged the safety issues with its own medical devices—issuing recalls affecting hundreds of thousands of patients nationwide and around the world.

If you or a family member has received an implantable medical device manufactured by Exactech, it is important that you find out if the device has been recalled. If it has, immediate revision surgery may be necessary. Even if revision surgery isn’t necessary currently, it may become necessary in the future, and issues with the device could be putting you or your loved one at risk for a variety of potentially serious medical complications.

What Patients and Families Need to Know About Exactech’s Implantable Medical Device Recalls

You can search for Exactech recalls using the U.S. Food and Drug Administration’s (FDA) Medical Device Recalls database. As of July 1, 2023, the company has 170 recalls on file with the FDA. Below, we provide a summary of the current status of the Exactech recalls, as well as some additional information for patients and families who need to file lawsuits to recover their losses:

Exactech Ankle Replacement Device Recalls

Exactech’s Vantage total ankle system is one of several devices that the company has recalled in recent years. This recall in particular relates to the risk of material deterioration within the device itself. Over time, this deterioration can cause the device to fail, and this can put patients at risk for both physical injuries and infections.

The Vantage total ankle system recall has been classified as a Class 2 Device Recall by the FDA. This means that the use of the defective implant “may cause temporary or medically reversible adverse health consequences.” While the risk of “serious adverse health consequences” is considered “remote” with a Class 2 Device Recall, many patients have suffered lasting consequences—physical, financial and emotional—as a result of receiving defective Exactech ankle replacement devices.

Exactech Hip Replacement Device Recalls

Exactech has recalled all hip implant devices that use the company’s Connexion GXL liner. There are several devices on this list. The Connexion GXL liner is prone to failure, deteriorating at a rate that requires premature revision surgery in many cases. Investigations have uncovered evidence suggesting that this is due to issues with the hip implant devices’ design, manufacturing and packaging.

Due to the risk of deterioration, Exactech has recommended that doctors closely monitor their patients for signs that revision surgery may be necessary. Common signs of complications caused by Exactech hip implant failure include pain, stiffness, joint pain and weakness, and difficulty walking.

Similar to the recall of Exactech’s Vantage total ankle system, the recall related to the company’s defective hip implant devices is a Class 2 Device Recall. Patients who have already had revision surgery should speak with a lawyer about recovering their costs, while those who have not yet had surgery should continue to monitor and consult with their doctors to determine if (or when) surgery may be necessary.

Exactech Knee Replacement Device Recalls

Exactech issued a recall in 2022 related to the company’s knee implant devices. This recall alone potentially affects hundreds of thousands of patients who received knee implants between 2004 and 2022. Our law firm is currently pursuing claims related to knee replacement device defects against the company.

One of the primary issues with Exactech’s knee replacement devices had to do with the devices’ packaging. Investigations uncovered that the packaging used failed to protect the devices from oxygen exposure prior to implantation. This, in turn, created a risk for oxidation—which can significantly increase the rate of the devices’ degradation.

For many patients, the first signs of an Exactech knee replacement device failure are swelling, instability, a grinding or clicking sensation, and pain while walking. Patients who are experiencing these symptoms and who received an Exactech Optetrak, Optetrak Logic or Truliant knee implant device in 2004 or later should consult with their doctors about the possible need for revision surgery.

Exactech Shoulder Replacement System Recalls

Exactech has also issued recalls affecting the company’s implantable shoulder replacement systems. These recalls relate to issues with the replacement systems themselves as well as the tools the company supplies for use during surgery.

Similar to issues with other types of joint replacement implants, issues with Exactech’s shoulder replacement systems can have a wide range of potentially serious consequences. These include everything from instability and infections to device failure and periprosthetic failure.

What to Know About Filing a Claim Related to an Exactech Recall

As of July 2023, numerous patients and families across the United States are pursuing claims against Exactech related to the company’s defective ankle, hip, knee and shoulder replacement devices. Those who have not yet taken legal action still have time to file in the majority of cases. If you think you may have a claim (or if you don’t know and would like to find out), here are some key factors to consider:

  • By issuing recalls, Exactech has acknowledged the defects affecting its implantable joint replacement devices in many cases.
  • Filing a successful claim for a defective medical device does not require proof of negligence—the simple fact that Exactech sold defective devices is enough to establish liability.
  • If you have a claim against Exactech, our firm can represent you at no out-of-pocket cost. Your legal fees (if any) will be calculated as a percentage of your recovery.
  • Filing a claim affords the opportunity to recover all of the costs of your (or your loved one’s) defective medical device implant. This includes medical expenses, lost earnings, pain and suffering, and various other financial and non-financial costs.
  • The first step in the process is simply to schedule a free initial consultation. We provide free initial consultations over the phone to patients and families nationwide.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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