Recently, the medical device manufacturer Exactech, Inc. announced a recall of more than 140,000 knee and ankle implants over concerns that the product packaging failed to protect the devices from potentially harmful exposure to oxygen. The personal injury lawyers at Console & Associates, P.C. are actively investigating the Exactech recall to determine the options of those affected by the recalled knee and ankle devices. 

Why Did Exactech Recall Its Knee Implants?

According to Exactech, the company’s recall of more than 147,000 knee and ankle devices was based on non-conforming packaging that failed to protect the devices from early exposure to oxygen. Evidently, the company’s knee and ankle implants are packaged in vacuum-sealed bags that are designed to protect the device. However, the company acknowledges that “most of our inserts manufactured since 2004 were packaged in out-of-specification … vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.”

The non-conforming packaging, in some cases, results in the devices being exposed to oxygen, which can begin a process called oxidation. As Exactech explains, this oxidation can “severely degrade” the components of the implant and “can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”

The Dangers Exactech Knee Implants Present

If you had an Exactech knee and ankle device implanted which was not packaged properly, the device may begin to break down much earlier than expected. More specifically, the plastic portion of the device may begin to degrade, the need for additional corrective surgery, also called revision surgery. The company notes that affected devices may also cause patients to experience bone loss, which may also result in the need for revision surgery.

The recall is classified as a “Class II recall,” which means that the use of the product “may cause temporary or medically reversible adverse health consequences.” However, this assumes that a patient’s health allows for the revision surgery. For those patients with compromised health, additional surgery may raise significant health risks.

Which Exactech Devices Have Been Recalled?

Currently, Exactech has recalled about 147,000 devices, all manufactured since 2004. The recall includes the following implants:

• OPTETRAK® - 60,926 devices implanted since 2004

• OPTETRAK Logic® - 60,518 devices implanted since 2004

• TRULIANT® - 24,727 devices implanted since 2004

• VANTAGE® - 1,561 devices implanted since 2004

If you had any of these devices implanted, there is a high probability that it was not properly packaged and may have been exposed to oxygen prior to being implanted. This may lead to oxidation of the device, which can cause the device to prematurely breakdown.

What to Do if You Had a Recalled Exactech Device Implanted

Those who underwent a knee or ankle replacement using an Exactech total knee or ankle device should consult with their surgeon to determine if the specific device used in the surgery was included in the recent recall. If so, your surgeon can evaluate the potential need for revision surgery. Additionally, patients with Exactech devices implanted should reach out to a product liability lawyer to learn about their options to hold the company liable through an Exactech recall lawsuit.

Patients and doctors both place a tremendous amount of trust in medical device manufacturers to create safe, effective products. However, when a manufacturer doesn’t take the time to ensure their product is safe, patients can suffer tremendously. Device manufacturers can – and should – be held accountable for the injuries caused by their products. An experienced product liability attorney can help you understand your rights and what you need to do to effectively bring an Exactech recall lawsuit.