The Cartiva implant is a medical device a company. Cartiva sold a toe implant in the United States from about 2016 to 2024. After lawsuits and a recall, the Cartiva to implant is now off the market. Read about the Cartiva story here.

The Cartiva Implant Story

A company named Cartiva made a product using what they presented as new technology. The flagship product, the Cartiva toe implant, came to market via a pre-market application (“PMA”). Cartiva filed its PMA with FDA in 2015. FDA approved the toe implant in 2016.

The Cartiva implant introduced a new treatment option for hallux rigidus. More specifically, Cartiva was for the “treatment of patients with painful degenerative or post-traumatic arthritis (hallux limitus or hallux rigidus) in the first metatarsophalangeal joint with or without the presence of mild hallux valgus.

Exciting New Technology

Cartiva excited several surgeons. Indeed, some called it the most advanced product yet. They hoped they had a solution for patient big toe pain. The Cartiva implant was game-changing, initially. Early reports showed improvement.

Cartiva Risks Arise

Then starting in 2020, concerns about the Cartiva implant arose quietly among some doctors. As some researchers wrote, “It represents the unfortunately repetitive rise and fall of new surgical devices accepted too early in the usage life cycle before mid- to -long-term outcomes exist.”

The toe implant does not consistently stay in place, it does not consistently relieve pain; put simply, it fails and the surgeon removes it. They fuse patients’ big toe.

Nevertheless, Cartiva continued selling, and patients continued hurting. Cartiva started to lose market share and competitors seized the opportunity. In fact, one company created a product specifically to remove the toe implant, called AVITRAC (Cartiva backwards).

Finally, eight years after it hit the market, the Cartiva saga is coming to an end. We had a Cartiva recall that instructed people to monitor patients and look closely at the instructions for use. Further, the company initiated a withdrawal; the Cartiva implant is off the market.

Cartiva Toe Implant Recall and Cartiva Withdrawal

There have been significant developments concerning Cartiva since we started working on this matter years ago. The most significant news we can share is about the toe implant recall.

The Cartiva Recall: What You Need to Know

The Cartiva toe implant, a synthetic cartilage replacement Cartiva designed for patients with arthritis in the big toe joint, faced increasing scrutiny since it hit the market in 2016. Reports of Cartiva implant failure, pain, and the need for revision surgery shook doctors’ confidence in it.

Many patients who received the toe implant expected long-term relief. Instead they suffered complications that required additional procedures. If you or a loved one had a Cartiva implant and suffered from persistent pain, loss of mobility, or device failure, you may have legal options. As concerns grow over a potential Cartiva recall, it’s crucial to stay informed about FDA updates, patient lawsuits, and your rights. Contact us today to learn how we can help you pursue compensation for your suffering.

The Cartiva Implant Recall Details

Stryker issued an urgent safety notification and recall for the Cartiva Toe Implant, a Synthetic Cartilage Implant (SCI). Announced October 31, 2024, this marks a critical development for Cartiva implant patients, surgeons, and hospitals across the United States. The Cartiva recall follows new post-market data revealing higher-than-expected rates of adverse outcomes, including revision surgeries, implant failures, and other complications.

What is the Cartiva Toe Implant Recall?

The Cartiva implant recall is a market withdrawal of this medical device. The Cartiva toe implant fails more than anticipated. It causes more problems than originally thought when FDA approved it in 2016 after Cartiva sought approval for its toe implant in 2015.

A True Recall In the Usual Sense – the Cartiva Toe Implant is Off the Market

Although many people think a product “recall” involves taking product off the shelves, that is not always the case. That’s true particularly with medical devices. Many “recalls” are really just notices or modifications to the instructions for use (e.g., indications, instructions, warnings). Removing the product from the market entirely can be part of a recall, but isn’t always.  Here, Stryker is removing the Cartiva toe implant from the market, truly calling it back from the shelves.

Stryker Did the Right Thing by Withdrawing Cartiva Toe Implants

Stryker did  not design or initially sell the Cartiva toe implant. Rather, a group of people had the idea, deployed the concept in various ways in Europe. They decided to create the toe implant. It would become a big deal in the podiatric and toe implant world, for a bit.

Cartiva sought and obtained FDA approval in the US. They presented data from a study known as the MOTION study. The suggestion was that Cartiva failed in a small number of patients, less than 10% of the time. FDA approved the Cartiva toe implant in 2016.

Another company bought Cartiva. Then Stryker acquired the Cartiva toe implant. Stryker continued to sell Cartiva until the 2024 toe implant recall.

Withdrawing the Product Protects Patients

When a product fails, we expect the company to act. Labeling should change, the design updated, or the product removed. Unfortunately, some companies do nothing. Stryker did the right thing here with Cartiva.

In 2020, reports emerged that Cartiva was not functioning in patients as expected. Doctors reported having to remove the Cartiva toe implant far more than expected because it was not providing promised pain relief and causing problems. Surgeons moved away from the Cartiva toe implant.

By now it seems widely accepted that Cartiva implants fail many times more than originally represented. Because the Cartiva toe implant fails so much, Stryker made the right decision to recall and remove it.

A Cartiva Lawsuit Goes to Trial Next Year

A court in West Virginia issued a scheduling order in a Cartiva toe implant lawsuit. Key deadlines include the completion of discovery by September 12, 2025, expert disclosures beginning in July 2025, and a jury trial set for February 9, 2026. Mediation is mandatory and the parties must complete it before the pretrial conference in January 2026. Our firm continues to represent hundreds of clients affected by this device and is closely monitoring these legal developments. We’re hopeful there is no adverse ruling from this case that emboldens the defendants.

If you or a loved one have experienced complications with a Cartiva implant, contact KBA Attorneys for a case evaluation, 855-KBA-LAWS (522-5297).

KBA Attorneys Has Been Leading the Charge against the Cartiva Toe Implant

KBA Attorneys have extensive experience as medical device attorneys. Not surprisingly, KBA Attorneys has been at the forefront of the Cartiva toe implant matter from the very beginning. KBA discovered the problem years before some other law firms jumped into the fray.

We monitor FDA regulatory activity and peer review literature. After interning at the FDA, one of KBA’s founder went on to work as a product liability attorney representing companies. Then he switched sides to  represent people medical devices injured. He developed an expertise in post market surveillance by working with leading industry experts. This gives KBA a unique advantage and helps us find emerging cases like the Cartiva toe implant.

After learning about Cartiva, we did our due diligence. Our attorneys spoke with surgeons who implanted Cartiva. We engaged experts who removed the Cartiva toe implant. Digging into the Cartiva pre-market clinical study and post market data, we thought we had a case.

Obviously we at KBA now feel vindicated and are ecstatic for our Cartiva clients. This decision also bolsters our legal arguments against defenses we anticipated like preemption, an issue with which our attorneys, including the partner leading the charge against Cartiva, Whitney Butcher, have handled in other cases, including BHR hip implants.

We work with another law firm to bring the power of two legal teams to tackle these Cartiva implant cases. Make no mistake, our firm is involved personally – we do not refer cases out. Nonetheless, we are attacking the Cartiva toe implant issue from two fronts. Our co-counsel explains how we got here.

At KBA Attorneys, we are committed to helping individuals navigate the complexities of medical device recalls and the legal ramifications. Our team has extensive experience with medical device litigation, including Cartiva-related issues, and we are here to support you if you or a loved one has been affected by the Cartiva implant.

What Is the Cartiva Toe Implant?

The Cartiva Synthetic Cartilage Implant is a molded cylindrical implant designed for the treatment of first metatarsophalangeal (MTP) joint osteoarthritis, commonly affecting the big toe joint. We sometimes say it looks like a gum drop, a popular candy from our childhood. Composed of an organic hydrogel polymer made of polyvinyl alcohol and saline, the Cartiva Toe Implant mimics the mechanical properties of natural cartilage. Its purpose is to replace damaged cartilage, reduce pain, and maintain range of motion.

The toe implant comes in multiple sizes (6mm, 8mm, 10mm, and 12mm) and is implanted through a press-fit procedure in the metatarsal head of the MTP joint. Since its FDA approval in 2016, Cartiva has been marketed the Cartiva implant as a less invasive alternative to traditional fusion surgeries for MTP joint osteoarthritis.

We provide a history of Cartiva on our main page here, check it out.

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Why Did Stryker Recall the Cartiva Toe Implant?

Stryker’s recent safety notice cites post-market data and published studies showing that patients with the Cartiva Toe Implant have experienced complications at rates higher than those reported during premarket and post-approval studies. In plain speak, it failed more than expected. These complications include:

• Revision or removal, often requiring additional surgeries.
• Subsidence (sinking into the bone).
• Displacement of the Cartiva toe implant from its intended position.
• Persistent or worsening pain at the Cartiva implant site.
• Nerve damage.
• Fragmentation of the Cartiva implant material.

These issues led to the recall of all Cartiva toe implant  devices in the U.S. The affected product catalog numbers include CAR-06-US, CAR-08-US, CAR-10-US, and CAR-12-US, distributed between July 2016 and October 2024.

https://www.stryker.com/content/dam/stryker/foot-and-ankle/resources/CartivaFSN30Oct2024_US.pdf

Implications for Cartiva Patients and Healthcare Providers

Bottom line, this is the end of Cartiva. This recall means that Cartiva toe implants are no longer available on the U.S. market. Per the notice, healthcare providers should remove the Cartiva implant from their inventory and cease use immediately.

Stryker directs hospitals and clinics:

1. Locate and quarantine all affected devices.
2. Return unused implants to the manufacturer.
3. Notify patients who have been treated with Cartiva SCI about potential risks and monitor them for complications.

For patients, this Cartiva recall highlights the importance of ongoing medical follow-ups, particularly if you are experiencing new or worsening symptoms such as pain, stiffness, swelling, or difficulty walking.

What Should You Do If You Have a Cartiva Toe Implant?

Carvia patients experiencing pain need to call their doctors. If you have a Cartiva Toe implant, it’s essential to take proactive steps to protect your health. We cannot and do not give medical advice. So the first step is most important. 

1. Contact your doctor: If you are experiencing any symptoms, you can schedule an appointment with your doctor or healthcare provider. Your doctor can evaluate the Cartiva toe implant’s condition and recommend the appropriate course of action.
2. Monitor your symptoms: Be vigilant for signs of implant failure, such as pain, swelling, or reduced mobility. Report these symptoms promptly to your healthcare provider.
3. Consider legal options: If you’ve experienced Cartiva implant failure symptoms or complications or required additional surgeries due to a Cartiva implant, we will evaluate your case for free and see if you can obtain compensation for medical expenses, lost wages, and pain and suffering.

What to do if your Cartiva implant failed?

In addition to what we noted above, you should consult a Cartiva toe implant lawyer. A Cartiva implant attorney can evaluate whether you have any potential Cartiva toe implant legal claims. A Cartiva implant failure lawsuit may be an option, among others. At this time, there is not a Cartiva toe implant class action in this country, to our knowledge.

At KBA Attorneys, we understand the challenges that Cartiva patients face when dealing with defective medical devices. We have spoken with hundreds of Cartiva patients. We have seen their photos, reviewed their x-rays, and learned their stories. Our team is here to provide the guidance and support you need to pursue justice concerning the Cartiva implant.

Cartiva Implant Failure Symptoms

A Cartiva implant is a small device doctors put in your big toe joint to help it move better when you have arthritis. Sometimes, this implant can start having problems. Here’s what to watch out for:

Pain Problems: Your toe might hurt all the time or start hurting again after it felt better. It might especially hurt when you wear shoes or walk around.

Physical Changes: Your toe might not bend as well as it should. It might feel stiff or look swollen. Sometimes the toe might even look crooked or different than before.

Movement Issues: You might hear clicking sounds when you move your toe. The toe might feel wobbly when you walk, or you might have trouble doing things you normally do, like walking or exercising.

Other Signs:

• Extra bone might grow around the implant
• The area around your toe might feel hot and swollen
• You might start walking differently to avoid toe pain
• The skin around your toe might get irritated

If you notice any of these problems, tell your foot doctor right away. They can check your toe and help figure out what to do next. Sometimes they might need to take the implant out or try something else to help your toe feel better.

Signs Your Cartiva Implant Might Be Having Problems

How KBA Attorneys Can Help with Cartiva 

KBA Attorneys has a long history of advocating for victims of defective medical devices, including those impacted by the Cartiva Synthetic Cartilage Implant. From the outset of the Cartiva case, we engaged medical experts to understand the science and medicine involved. We dug deep into what the long-term consequences are from a Cartiva implant. 

Having served hundreds of clients, we understand what the experience has been for patients who had the Cartiva toe implant. We appreciate the individual experience each has had as we have worked up every single one of our client’s cases personally, individually, and with due care. 

We have written extensively about Cartiva-related issues, helping patients and their families understand the risks and legal implications of this device. Here are some of our most recent blog postings about Cartiva toe implants. 

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Metatarsal Phalangeal Joint Replacement and Cartiva Implant Lawsuits

The Biggest Failures of Cartiva Toe Implants 

Problems with Cartiva Toe Implants

Big Toe Joint Replacement: What You Need to Know

Our dedicated team of attorneys have extensive experience in medical device litigation and has the expertise to handle complex cases involving:

• Defective product design
• Failure to warn about known risks
• Post-market surveillance failures

We have been here and will continue to be here for Cartiva toe implant patients. We take the time to hear your story, analyze the facts and the law, and present a compelling case on your behalf.

Other Firms Send Their Cases to KBA Attorneys because We Are the Committed Cartiva Toe Implant Attorneys – Contact Us to See Why

Many firms advertise for cases like the Cartiva toe implant matter. We are blessed with long-standing relationships with some of the largest firms across the country and the biggest advertisers. Other law firms send their clients to KBA because we are responsive to our clients, we have the experience and expertise to maximize recovery for our clients, and we have handled complex cases like the Cartiva implant lawsuit before. We are empathetic and we advocate, like true professionals.

At KBA Attorneys, we are here to help you navigate this challenging time. If you have questions about the Cartiva recall or need legal assistance regarding a Cartiva toe implant, contact us today for a free consultation. Together, we can work toward holding manufacturers accountable and securing the compensation you deserve. Call now, 855-KBA-LAWS (522-5297) or email ToeImplants@KBAAttorneys.com.  

Do I need to Have the Cartiva removed to Qualify?

No. We look at each case individually. Some patients cannot have the Cartiva toe implant removed. There are many reasons for this. We’re happy to speak with you and evaluate your situation. There are important deadlines in play, so contact us today for a free consultation. Call now, 855-KBA-LAWS (522-6297) or email ToeImplants@KBAAttorneys.com.

Cartiva Recap – Cartiva Synthetic Cartilage Implant Recall – What You Need to Know

What Is the Cartiva Implant?

The Cartiva Synthetic Cartilage Implant (SCI) was designed to replace damaged cartilage in the big toe joint (first metatarsophalangeal joint) for patients suffering from arthritis or hallux rigidus (stiff big toe). It was marketed as a revolutionary, long-lasting alternative to joint fusion surgery, allowing patients to maintain motion in the toe. However, many patients experienced implant failure, pain, and the need for revision surgery—raising concerns about the device’s safety.

Why Are Patients Filing Lawsuits Against Cartiva?

Although Cartiva was initially FDA-approved, post-market reports and patient complaints suggest high failure rates. Common issues include:

• Implant dislocation or fragmentation
• Continued pain and stiffness after surgery
• Implant extrusion (popping out of place)
• Bone loss or cyst formation around the implant
• The need for additional surgeries (often requiring fusion or bone grafting)

Patients who have suffered from these complications are now exploring legal options to recover damages for medical bills, pain, lost wages, and other losses.

Is There a Cartiva Recall?

Yes, there is an FDA notice about the Cartiva recall. In fact, the Cartiva implant is no longer on the market. Growing litigation and reports of implant failures may lead to further scrutiny. Surgeons are increasingly advising against Cartiva in favor of more reliable alternatives.

Do You Qualify for a Cartiva Lawsuit?

If you had a Cartiva implant and experienced severe pain, implant failure, or needed revision surgery, you may be entitled to compensation. Our legal team at Ketterer, Browne & Associates is actively investigating Cartiva lawsuits and can help determine if you qualify.

You may be eligible if you:

• Had a Cartiva implant surgery
• Experienced implant failure, dislocation, or persistent pain (Cartiva failure)
• Required a revision surgery to remove or replace the implant (Cartiva removal)
• Were told your Cartiva implant failed or was ineffective

How Can a Lawyer Help With Your Cartiva Claim?

Pursuing a Cartiva lawsuit or a Cartiva settlement claim can help you recover compensation for:

• Medical expenses (implant removal, revision surgery, rehabilitation)
• Pain and suffering
• Lost wages or diminished earning capacity
• Long-term disability or mobility issues

Our attorneys have extensive experience handling defective medical device lawsuits and can guide you through the claims process.

Take Action Now – Get a Free Case Evaluation

If you or a loved one has suffered complications from a Cartiva implant, you don’t have to go through this alone. Contact us today for a free consultation to explore your legal options.

• Call us at 855-KBA-LAWS (522-5297)
  Email us at ToeImplants@KBAattorneys.com 
• Submit a form
• Live chat

Time may be limited to file your claim, so don’t wait. Let our experienced legal team fight for the compensation you deserve.