Exactech Ankle Lawsuit | 2025 Latest Updates

Exactech, Inc. has issued a nationwide recall for thousands of polyethylene plastic inserts used in ankle and knee replacements because the plastic may wear early, causing the implant to fail prematurely and the need for painful revision surgery.
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If you or a loved one experienced implant failure, pain, swelling, or required revision surgery following an Exactech ankle replacement procedure, you may be entitled to pursue compensation.

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Exactech Ankle Lawsuit Overview

The Exactech ankle lawsuits center on the Vantage Total Ankle System, where polyethylene inserts were packaged in out-of-specification vacuum bags lacking a secondary oxygen barrier, allowing oxygen exposure. This packaging defect caused the inserts to degrade prematurely, leading to early device failure, pain, swelling, bone loss, and complications often requiring revision surgery.

Approximately 147,732 knee and ankle inserts, including a subset of Vantage Total Ankle System inserts, have been implanted in patients across the United States since 2004, with defective packaging increasing the risk of failure. The FDA classified the recall of these knee and ankle devices as Class II on October 4, 2021, with Exactech expanding the recall to all affected devices on February 7, 2022 [1].

Implant failure may occur from a defective implant or with time. Most implants last between 15 to 20 years in 85% to 90% of patients, according to Dr. Amar S. Ranawat of the Hospital for Special Surgery.

Latest Exactech Ankle Lawsuit Updates

March 5, 2025 – According to the Lawsuit Information Center, defective Exactech ankle and knee implants are the subject of ongoing litigation due to early device failure linked to improper packaging [2].

January 10, 2025 – LawFirm.com explains that Exactech ankle replacement devices were recalled after packaging defects led to accelerated wear and early implant failure.

October 29, 2024 – Reuters reports that Exactech filed for bankruptcy to manage thousands of lawsuits over its recalled implants, including defective ankle replacement devices.

August 5, 2024 – The FDA issued a safety alert regarding Exactech’s ankle replacement devices, warning that packaging issues may lead to early device failure [3].

Back in 2017, Exactech found itself defending personal injury cases involving abnormally high failure rates associated with its OPTETRAK knee replacement system.

Related Article: STAR Ankle Replacement Suits

FDA Reports and Statistics

The FDA classified the Exactech recall of Vantage Total Ankle Systems and knee replacement systems as a Class II recall on October 4, 2021, indicating that the recalled devices may cause temporary or medically reversible health issues, such as bone loss, pain, or surgical complications requiring revision surgery. According to Exactech’s recall notice, approximately 147,732 knee and ankle polyethylene inserts, including a subset of Vantage Total Ankle System inserts, have been implanted in the United States since 2004, with defective packaging increasing the risk of premature failure.

Data from Australian, New Zealand, and United Kingdom registries have shown that Exactech’s Optetrak knee implants have significantly higher revision rates compared to other similar knee implants, supporting the need for the company’s knee system recall. While no specific registry data for Vantage Total Ankle Systems is reported, the ankle recall was prompted by similar packaging defects identified in knee systems.

Exactech Knee Replacement

Exactech Ankle Injuries & Side Effects

The recalled Exactech ankle replacement systems can cause serious complications due to the premature degradation of the polyethylene inserts. Patients with these defective implants may experience:

  • Accelerated wear: Premature breakdown of implant components
  • Pain/inability to bear weight/grinding: Severe discomfort when walking or standing
  • Bone loss: Deterioration of bone tissue surrounding the implant
  • Component fatigue: Weakening of implant materials over time
  • Component cracking or fracture: Physical breakdown requiring revision surgery
  • Other symptoms: Noise, swelling, and instability in the ankle joint
  • Debris production: Release of particles into surrounding tissue

Do You Qualify for an Exactech Ankle Lawsuit?

You may qualify for an Exactech ankle lawsuit if:

  • You received a Vantage total ankle replacement system between 2004 and 2022
  • You experienced complications such as pain, swelling, inability to bear weight, or instability
  • You required revision surgery to correct problems with your ankle implant
  • You can provide medical documentation linking your injuries to the Exactech ankle implant

Of course, a lot can happen between now and the end of an Exactech class action lawsuit.  So any estimates are very speculative.

Related Articles:

See all related medical device lawsuits our attorneys covered so far.

Evidence Required for an Exactech Ankle Lawsuit

To successfully pursue an Exactech ankle lawsuit, you will need to provide:

  • Medical records confirming you received an Exactech Vantage ankle implant
  • Documentation of complications or symptoms related to implant failure
  • Records of any revision surgeries or additional treatments
  • Proof that your implant was among those affected by the recall

Damages You Can Recover

In an Exactech ankle lawsuit, you may be able to recover compensation for:

  • Medical expenses related to revision surgeries and ongoing treatment
  • Lost wages due to inability to work during recovery
  • Pain and suffering caused by implant failure
  • Potential punitive damages against Exactech

Exactech Ankle Recall Information

On February 7, 2022, Exactech expanded its recall to include all Vantage Total Ankle System polyethylene inserts packaged in out-of-specification bags, covering all such implants regardless of label or shelf life. The recall was necessary because the defective packaging lacked a secondary oxygen barrier, allowing oxygen exposure that caused the polyethylene inserts to degrade prematurely.

Exactech identified the packaging issue as starting around 2004, though its knee implants, such as the Optetrak system, have been marketed since 1992; the Vantage Total Ankle System was introduced in 2016. Patients with recalled Exactech Vantage Total Ankle implants experiencing new or worsening symptoms, such as pain, swelling, instability, or difficulty walking, should contact their healthcare providers for evaluation, potentially including X-rays. Exactech and the FDA do not recommend surgery for patients without symptoms.

Statute of Limitations for Exactech Ankle Lawsuits

The statute of limitations for filing an Exactech ankle lawsuit varies by state but typically ranges from 1-3 years from the date you discovered or should have discovered that your injuries were caused by a defective Exactech implant. Because of the 2022 recall announcement, the clock may have started ticking for many patients at that time.

Given these time constraints, it’s crucial to consult with an experienced attorney as soon as possible to ensure your legal rights are protected.

FAQs

1. Is There a Recall on Exactech Ankle Replacements?

Yes, there is a recall of Exactech ankle replacements, which was expanded on February 7, 2022. This recall includes all Vantage total ankle replacements and Optetrak, Logic, and Truliant knee replacements that were packaged in defective bags, regardless of the device’s label or shelf life.

2. What Is the Exactech Recall Compensation?

The Exactech recall compensation is designed to reimburse patients for certain out-of-pocket expenses related to visiting their surgeon. This may include copays, deductibles, and reasonable travel expenses incurred when seeing the surgeon who performed their primary surgery.

3. Who Is Eligible to File a Lawsuit in the Exactech Ankle Recall?

Individuals who have received a Vantage total ankle replacement and experienced complications due to defects in the implant or packaging are eligible to file a lawsuit in the Exactech ankle recall. This includes those who have undergone revision surgery as a result of the implant issues.

4. What Was Wrong With the Exactech Ankle Implants?

The Exactech ankle implants were packaged in defective bags that failed to adequately protect the polyethylene inserts from oxygen exposure. This exposure caused the inserts to degrade prematurely, leading to early device failure and complications requiring revision surgery.

5. Should I Accept Exactech’s Reimbursement Offer?

You should consult with an attorney before accepting any reimbursement offer from Exactech. According to information on Exactech’s claims website, patients who choose to file a claim for reimbursement may waive their right to file a product liability lawsuit against the company [4].

6. What is Ankle Replacement Surgery?

Ankle replacement surgery is a procedure for treating people with arthritis in their ankle joint. During the surgery, an orthopedic surgeon removes the diseased ankle joint and replaces it with an artificial joint made of metal, plastic, ceramic, or other materials.

7. How Long Do Ankle Implants Typically Last?

Implant failure may occur from a defective implant or with time. Most implants last between 15 to 20 years in 85% to 90% of patients, according to Dr. Amar S. Ranawat of the Hospital for Special Surgery.

8. What Complications Can Occur with Revision Surgery?

Complications associated with ankle revision surgery may include failure of bones to heal properly, postoperative infection, and damage to nerves or blood vessels. Revision surgery generally takes longer to complete than initial surgery and often carries a greater risk of complications.

Time is limited to pursue legal action for defective Exactech ankle implants. Most states have a statute of limitations of only 1-3 years from the date you discovered your injury was related to a defective implant.

At Schmidt & Clark, LLP, we offer:

  • Free, confidential consultations to evaluate your case
  • No upfront costs or fees to begin your case
  • Payment only if we win your case

Don’t delay in seeking the compensation you deserve for your Exactech ankle implant injuries.

Get a Free Exactech Ankle Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in product liability lawsuits. Our law firm is handling individual litigation nationwide and currently accepting new ankle implant complication cases in all 50 states.

Free Exactech Recall Claim Evaluation: Again, if you were forced to undergo revision surgery or suffered complications following knee or ankle surgery with a defective implant or failed device, you should contact our law firm immediately. You may be entitled to financial compensation for medical expenses by filing an Exactech Lawsuit and we can help.

References:

[1] https://www.exac.com/product/exactech-dhcp-letter/ 

[2] https://www.lawsuit-information-center.com/exactech-knee-replacement-lawsuits.html 

[3] https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication 

[4] https://www.exac.com/recall-information/ 

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