Exactech Replacement Recalls

Exactech recalled polyethylene liners in its knee, hip and ankle implants manufactured in 2004 or later because non-conforming packaging may cause the liners to degrade and fail early, potentially leading to bone loss and revision surgery. The recall affects about 533,160 devices.

This is an active lawsuit

See If You Qualify for an Exactech Lawsuit

If you are experiencing complications from your Exactech hip, knee or ankle replacement, you may be entitled to compensation.

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Last Modified: March 12, 2024
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Which Exactech Replacement Devices Are Being Recalled?

Recalled Exactech devices include almost all polyethylene liners in its knee, hip and ankle implants because of defective packaging that can cause polyethylene liners to degrade prematurely. Initially, the company recalled its GXL Connexion liners in June 2021 and later expanded the recall to all hip liners. In August 2021, the company issued a recall for its knee and ankle implants.

The FDA classifies these recalls as Class II. This means these recalled devices may cause serious injury or temporary illness.

Exactech manufactured the affected devices between 2004 and August 2021. This recall includes about 533,160 devices in total. In April 2022, Exactech said about 147,732 knee and ankle devices were implanted in the U.S. since 2004.

Recalled Exactech Devices
HipNovation, AcuMatch, MCSJune 202139,942
KneeOptetrak Logic, Truliant, ArthrofocusAugust 2021489,498
AnkleVantageAugust 20213,720
Sources: Exactech and FDA

“The Exactech recall goes all the way back to devices from 2004, and it’s basically company-wide and affects nearly every Exactech model. It’s different from other medical device recalls such as the DePuy ASR or Stryker Rejuvenate recalls because those were very specific models. In this case, it’s almost all of the Exactech replacements,” according to mass torts and product liability attorney Daniel Nigh.

The recall has led hundreds of people to file Exactech lawsuits. As of April 2024, there were 1,401 Exactech recall lawsuits pending in multidistrict litigation before the U.S. District Court for the Eastern District of New York.

In January 2024, the FDA warned about the Exactech Equinoxe Shoulder System’s safety because of its defective packaging, which resembled the packaging of other recalled hip, knee and ankle devices. But as of now, Exactech has declined to issue a recall. The FDA warned that these devices may have to be replaced to correct problems.

Lawyer Daniel Nigh discusses which Exactech replacements have been recalled.

Previously Reported Exactech Replacement Problems

Before the current recalls, Exactech faced problems with its joint replacements. Since the original Optetrak Knee System was introduced in 1992, it has had higher revision rates compared to other knee replacements. Data from Australia, New Zealand and the United Kingdom reported revision surgery rates increased as high as seven-fold compared to other devices.

It has also faced a whistleblower lawsuit that said the company knowingly gave faulty knee replacement devices to Medicare, Medicaid and Department of Veterans Affairs beneficiaries.

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Exactech Recall Timeline
  • January 2024:
    The FDA issued a Safety Communication for Exactech's Equinoxe Shoulder System, stating that it was packaged in defective packaging, but Exactech refused to issue a voluntary recall.
  • March 2023:
    The FDA issued a reminder that Exactech hip implant components made between 2004 and August 2021 have links to accelerated degeneration and revision surgery.
  • September 2022:
    The FDA classified the Exactech recall for its GXL liners as a Class II recall, with the potential for “medically reversible adverse health consequences.”
  • August 2022:
    Exactech expanded its hip replacement device recall to include all polyethylene components packaged in defective bags. The company issued an urgent letter to health care professionals.
  • July 2022:
    Exactech encouraged hip replacement patients to get a medical evaluation if their device contained a recalled polyethylene liner.
  • April 2022:
    Exactech sent an Urgent Medical Device Correction Letter to surgeons, hospitals and health care professionals alerting them to potential polyethylene liner breakdown and damage due to improper packaging. The problem affected approximately 80% of liners manufactured since 2004.
  • February 2022:
    Exactech issued an urgent recall of the polyethylene liners packaged with its Vantage Total Ankle System. The recall affected more than 2,000 liners.
  • June 2021:
    Exactech recalled some of its GXL liners for Novation, AcuMatch and MCS hip replacement devices related to premature wear. The company issued an urgent warning to surgeons and health care professionals.
Show More

Why Are Exactech Replacements Being Recalled?

According to Exactech, most of their knee, hip and ankle replacements manufactured since 2004 came with polyethylene plastic inserts packaged in “out-of-specification” bags that could allow oxygen to reach the inserts. This increased oxygen exposure could cause the liners to severely degrade the liners.

While Exactech has officially said the recall was related to faulty vacuum bag packaging that could cause early damage to implant liners, Daniel Nigh believes there’s more to the recall.

Attorney Daniel Nigh
“We think there's more to the reason why the polyethylene liners are defective as opposed to just the vacuum bags. We believe that it has to do with how the polyethylene liners were manufactured.”
Daniel Nigh, mass torts and product liability attorney

The U.S. Food and Drug Administration classified the recall as a Class II. This means the recalled liners could lead to temporary or reversible health consequences.

Potential injuries associated with recalled knee 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 implants.

Problems with Recalled Exactech Knee Implants

According to Exactech, recalled knee and ankle devices may be associated with problems from increased premature wear to increased revision rates.

Issues with recalled knee implants include:
  • Higher than expected revision rates
  • Increased risk of polyethylene (plastic) wear
  • Potential development of bones loss (osteolysis)
  • Revision rates because of polyethylene wear increased three- to seven-fold in the Optetrak compared to other knee replacements

The company said these problems were potentially related to the defective packaging that caused oxidation and degradation of the plastic inserts in the knee implants.

Exactech Hip Implant Early Failure

Exactech has informed surgeons that under certain conditions patients with hip replacements that use the GXL liner may be at risk for higher wear rates.

While many implants last for 10 to 15 years, studies showed the average time to revision for Exactech hip implants with defective liners was approximately five years. Most people who suffered premature wear complained of hip or groin pain, but the company also observed that premature wear in asymptomatic patients.

Lawyer Daniel Nigh explains the reason why Exactech recalled its hip implants.

Does the Exactech Implant Recall Affect Me?

Exactech notified surgeons about the recall and your surgeon may contact you to schedule a follow-up appointment if your implant is on the recall list. But if you are concerned and don’t hear from your doctor, you can contact their office to see if your implant has been recalled. Exactech may also have sent you a recall letter.

“My wife had a right knee replacement utilizing Exactech prosthetics approximately nine years ago. All went well until the last two years when she began having trouble. About the time that the knee pain was getting worse, we were notified by Exactech about the recall due to the improperly stored pad prior to the original surgery,” RG, who used initials to identify himself for privacy reasons, told Drugwatch.

In addition, you can look up your knee or ankle implant serial number on Exactech’s website. The serial number should be in your medical records. You can also contact Exactech directly at 1-888-912-0403.

Possible Implant Failure Symptoms

“As a pain management specialist, I’ve worked with countless patients who have suffered from chronic pain due to hip or knee implant issues. One of the primary symptoms that we often see in these patients is pain or discomfort that persists beyond the expected recovery period,” Dr. Thomas Pontinen, double board-certified pain management expert and surgeon, told Drugwatch.

The number one symptom of a faulty implant is pain, but make sure you contact your doctor to see if you need to monitor your implant for potential future issues even if you don’t have symptoms now.

Symptoms to watch for include:
  • Clicking in your knee, ankle or hip
  • Inability to bear weight
  • Instability
  • Noises such as grinding coming from the implant
  • Pain while walking
  • Swelling in the joint

Usually, symptoms associated with polyethylene wear relate to bone loss or the release of excessive particle debris from the degraded liner. However, some people may suffer bone loss, also called osteolysis, without symptoms.

“One of the primary symptoms that we often see in these patients is pain or discomfort that persists beyond the expected recovery period.”
Dr. Thomas Pontinen, double board-certified pain management expert and surgeon

If you have any of these symptoms, contact your doctor right away. They can discuss treatment options, including potential revision surgery to replace the defective insert or the entire device or a plan for pain management.

What To Do If the Recall Impacts You

If the Exactech knee and ankle recall impacts you, schedule an appointment with your surgeon if they have not already contacted you. You can discuss the risks and benefits of potential revision surgery with your doctor.

But if you aren’t having problems, your doctor may just continue to monitor you because Exactech doesn’t recommend surgery if you are asymptomatic. Early device wear and bone damage may occur even without symptoms, so monitoring your device is crucial.

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. Exactech is working with a third-party company called Broadspire to handle claims.

An Exactech claim may not reimburse you for other physical or emotional damages. Lawyers are currently investigating Exactech claims, and patients may choose to file Exactech replacement lawsuits for compensation for medical bills, lost wages, pain and suffering and other damages.

Even if you don’t have symptoms, consider speaking with an attorney to preserve your right to file a lawsuit, because some states have deadlines of as little as one year to file a claim.

Please seek the advice of a medical professional before making health care decisions.