Exactech Recall Affecting Many with Joint Implants Nationwide

In 2021, Exactech issued a recall for over 147,000 knee and ankle implants and over 90,000 hip implants across the United States. Implants created in 2004 or later may have been compromised due to packaging issues, potentially leading patients to suffer from bone loss and revision surgery.

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Exactech Implant Litigation Updates

Exactech has initiated another recall, this time for their Equinoxe Shoulder System devices. These devices were manufactured by Exactech between 2004 and August 2021 and were packaged in defective bags. Similar to the hip and knee implants from before, these devices were missing one of the oxygen barrier layers that protect the devices from oxidation. A chemical reaction with oxygen can degrade plastic components over time. 

In the latest development within the Exactech mass action MDL, a new status conference has been slated for March 13, 2024. This session will discuss the current state of the litigation, addressing key issues surrounding discovery and the selection of future bellwether trial. Exactech looks to slow down the trial process, with their legal team proposing a minimum four-month gap between concluding expert discovery and starting the first bellwether trial. 

The magistrate judge issued an amended Case Management Order to detail how to preserve specimens and medical devices, which are the crucial pieces of evidence in these cases. Third-party medical evidence storage providers will be used to store and handle these materials.

A claim for a whistleblower lawsuit was filed against Exactech for allegedly violating the False Claims Act by supplying defective knee replacement devices to beneficiaries of Medicare, Medicaid, and the Department of Veterans Affairs. If won, this case has the potential to interfere with the personal injury claims filed.

The pretrial discovery process has been relatively slow. The slow pace of discovery is causing frustration for a lot of plaintiffs who want these cases to move forward to bellwether trials.

In mid-December of 2023, Judge Garaufis named 27 lawyers to the plaintiffs’ leadership committees for the Exactech recall litigation. 

Exactech Recall

Overall, joint implants are a great option for those who suffer from chronic pain or permanent damage in their knee, ankle or hip. Unfortunately, sometimes these products can have manufacturing issues that result in premature failure.

In February 2022, Exactech (a company that creates joint replacement implants and instruments) expanded the recall they issued last year to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life,” according to an Exactech recall notification. They have recalled nearly 148,000 knee / ankle replacements and roughly 90,000 hip replacements.

*Another recall was issued in April 2024 for their Equinoxe Shoulder System implants. These are medical devices used to replace painful, shoulder joints due to osteoarthritisosteonecrosisrheumatoid arthritis, and/or loss of normal structure and function. 

Recalled Exactech knee and ankle replacements include:

  • Optetrak All-Polyethylene CR Tibial Components
  • Optetrak All-Polyethylene PS Tibial Components
  • Optetrak CR Tibial Inserts
  • Optetrak CR Slope Tibial Inserts
  • Optetrak PS Tibial Inserts
  • Optetrak Hi-Flex PS Tibial Inserts
  • Optetrak Logic CR Tibial Inserts
  • Optetrak Logic CR Slope Tibial Inserts
  • Optetrak Logic CRC Tibial Inserts
  • Optetrak Logic PS Tibial Inserts
  • Optetrak Logic PSC Tibial Inserts
  • Optetrak Logic CC Tibial Inserts
  • Truliant CR Tibial Inserts
  • Truliant CR Slope Tibial Inserts
  • Truliant CRC Tibial Inserts
  • Truliant PS Tibial Inserts
  • Truliant PSC Tibial Inserts
  • Vantage Fixed-Bearing Liner Component
Exacttech Knee Replacement Recall

If you’re unsure if you are affected, you use can use Exactech’s website to look up the serial number of your implant.

Why Are Exactech Joint Replacements Being Recalled?

According to Exactech, knee and ankle replacements manufactured since 2004 using polyethylene plastic inserts were packaged in “out-of-specification” bags. This could have allowed oxygen to reach the plastic lining of the insert. Increased oxygen exposure could cause severe degradation of the liners, causing premature wear. An insert that was suppose to last for 15-20 years, is now degrading in 5-10 years.

The U.S. Food and Drug Administration classified the recall as a Class II. Potential injuries associated with the recalled knee, hip and ankle liners include early failure, bone loss and component fracture that could lead to revision surgery. Revision surgery is a more complicated surgery than a primary joint replacement and often requires longer surgery times and special equipment.

example joint replacement

Does the Exactech Recall Affect You?

Surgeon’s who implanted Exactech inserts may have received a notification from the manufacture regarding the recall. If you believe you could have been affected, you could schedule a follow-up appointment to discuss the recall news with your doctor or primary care provider. Can you also use the Exactech website if you have your product information already.

Signs of Wear on Exactech Joint Implants

Those affected by the recall have typically gone through a revision surgery to correct the damage caused by the faulty implant after suffering through certain symptoms. If you are experiencing symptoms, make sure to notify your doctor. Symptoms to watch for include:

  • Strange noises or sounds coming from your implant area (knee, ankle or hip)
  • Inability to bear weight
  • Instability
  • Pain while walking
  • Swelling in the joint area
  • Pain while initiating movement
  • Dislocation
  • Loosening of the joint

Our experienced attorneys for Exactech knee replacements or hip replacements can help you get the compensation you need

Like other product liability cases, you should discuss all of the risks and benefits of potential revision surgery with your doctor. If you don’t have immediate problems from your implant, your doctor may elect to monitor for future changes.

Some patients may choose to contact Exactech to be reimbursed for out-of-pocket costs, such as medical bills from doctor visits or potential revision surgery. These claims with the manufacture may not cover all of the damages accrued during the ordeal. Our firm is currently accepting Exactech claims, and patients may choose to file Exactech replacement lawsuits for compensation for medical bills, lost wages, pain and suffering and other damages. We will help you through each step of the process to make sure you are well taken care of.

Do You Have an Exactech Joint Implant Claim?

Our attorneys and support staff will stop at nothing to get you all the compensation you deserve for your damages. A typical Exactech case we file includes the following:

  • A defective Exactech branded implant (Knee / Hip / Ankle) which was implanted in the year 2004 or later.
  • A defective Exactech branded shoulder implant which was implanted between the years 2004 and 2021.
  • You had a revision to your implant or spoke to a doctor about scheduling a revision surgery
  • You’ve experienced symptoms like the ones listed above

Not sure if your implant fits these criteria? You can give us a call, chat with us using the chat feature on the homepage, or email us to discuss your situation and learn whether you have cause to pursue an Exactech lawsuit.

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One Comment

  1. I’ve had2 revisions and2 dislocations,in the last 7months. This is my 4 hip in total. Still have not been released by doctor,in recovery still.clayton

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