What Patients Should Know About the Cartiva Toe Implant Recall

For people who have undergone surgery to treat arthritis in the big toe, the Cartiva Synthetic Cartilage Implant was intended to offer an alternative to joint fusion. The device was designed to reduce pain while preserving movement in the toe. However, patients who received a Cartiva implant may now have questions about the device following a recall issued in 2024.

The U.S. Food and Drug Administration (FDA) lists the Cartiva Synthetic Cartilage Implant recall as an open, classified recall. The agency reports that patients with affected implants may experience higher-than-expected rates of complications, including pain, implant subsidence, displacement, nerve damage, fragmentation, implant removal, and revision surgery. The FDA identified device design as the cause of the recall.

For patients who received a Cartiva implant several years ago, the recall may raise important questions. What exactly was recalled? What complications can occur? And what should you do if you have experienced problems since your surgery?

What Is the Cartiva Toe Implant?

The Cartiva Synthetic Cartilage Implant is a medical device used to treat painful arthritis in the first metatarsophalangeal (MTP) joint, which connects the big toe to the foot. The FDA approved the device in 2016 for patients with painful degenerative or post-traumatic arthritis, including conditions such as hallux rigidus and hallux limitus.

Cartiva was designed to provide an alternative to traditional fusion surgery. Rather than permanently joining the bones of the joint together, the implant was intended to preserve movement while reducing pain.

While FDA approval means a medical device has met the agency’s requirements for its intended use, it does not guarantee that every implant will perform as expected in every patient. Problems may become more apparent as devices are used by larger numbers of patients and additional safety information becomes available.

Why Was the Cartiva Implant Recalled?

The Cartiva Synthetic Cartilage Implant was the subject of a recall initiated on October 31, 2024. The FDA posted the recall in December 2024 and classifies it as a Class 2 recall. The recall involves Cartiva implants in several sizes, including the 6 mm, 8 mm, 10 mm, and 12 mm versions. According to the FDA, the affected products were distributed between July 2016 and October 2024.

The agency reported a higher-than-expected occurrence of several complications among patients who received the affected devices. These include implant subsidence, displacement, pain, nerve damage, fragmentation, implant removal, and the need for revision surgery. The FDA identified device design as the cause of the recall.

That does not mean every person with a Cartiva implant will experience a problem. However, the recall is important for patients who have developed symptoms or complications following their surgery because it provides information about problems that have been reported with the affected devices.

What Problems Can a Cartiva Implant Cause?

Cartiva patients may experience different complications depending on their individual circumstances. Some may develop ongoing or worsening pain in the big toe, while others may experience stiffness, swelling, weakness, or difficulty walking. One concern identified by the FDA is implant subsidence. This occurs when the implant settles or moves farther into the surrounding bone than intended. Patients may also experience displacement, meaning the implant moves from its intended position.

In some cases, complications can become serious enough to require another procedure. Implant removal or revision surgery may be necessary when the device is no longer functioning as intended or when a patient continues to experience significant symptoms.

The FDA’s original safety information for Cartiva also identified potential complications such as implant loosening, dislodgement, fracture, bone loss, nerve damage, progressive arthritis, and conversion to a fusion procedure. These complications do not necessarily mean that a patient’s implant has failed. Foot and toe pain can have many causes, so anyone experiencing new or worsening symptoms should discuss them with a qualified healthcare professional.

What Should Cartiva Patients Do After the Recall?

If you received a Cartiva implant, you do not necessarily need to assume that something is wrong. However, knowing whether your implant is affected by the recall can give you a better understanding of your situation. Patients who have experienced persistent pain, difficulty walking, swelling, stiffness, nerve problems, or other changes after Cartiva surgery should discuss those symptoms with their doctor. A healthcare provider can determine whether additional evaluation, imaging, or treatment may be appropriate.

It is also important to keep copies of your medical records. Surgical records, imaging studies, information about the specific implant you received, and records of follow-up treatment can all help document what happened. If you ultimately needed implant removal or revision surgery, those records may be particularly important.

Could You Have a Cartiva Implant Injury Claim?

A product recall does not automatically mean that every affected patient has a legal claim. Whether someone may have a case depends on the circumstances surrounding the implant and the injuries they experienced. For example, an evaluation may consider what type of Cartiva implant was used, when it was implanted, what symptoms developed, whether the device failed or moved, and whether additional medical treatment or surgery was required. Medical records and other evidence may help establish whether the patient’s injuries can be connected to the device. The FDA recall itself does not establish that a particular patient’s injury was caused by the Cartiva implant. However, it may be an important piece of information when evaluating a potential defective medical device claim.

Alonso Krangle Fight for Victims After a Cartiva Implant Injury

If your Cartiva Synthetic Cartilage Implant failed or you’re experiencing pain, swelling, or stiffness after surgery, Alonso Krangle can help. Our attorneys represent patients nationwide in claims against Stryker and Cartiva, holding them accountable for defective medical devices that cause lasting harm. Call us at 800-403-6191 or contact us online for a free consultation and confidential case evaluation.