Lawsuits over the recalled Cartiva big toe implant now have court-appointed lawyers in charge on both sides, a step that sets up the next phase of the federal litigation against Stryker and the companies it acquired. Twenty-one cases were pending in the consolidated proceeding as of October 1, 2026, and the exchange of evidence has not yet begun.
The cases are coordinated in multidistrict litigation in the Eastern District of Arkansas, MDL No. 3172, before Chief Judge Kristine G. Baker. They allege that the Cartiva Synthetic Cartilage Implant, a small hydrogel plug placed in the joint at the base of the big toe, failed far more often than patients and surgeons were told, leaving many people with bone damage and a second, more difficult surgery.
Where the Cartiva MDL Stands
The Judicial Panel on Multidistrict Litigation created MDL No. 3172 on February 5, 2026, sending Cartiva cases filed in federal courts around the country to Judge Baker in Little Rock. Cartiva opposed centralizing the cases, and the panel disagreed. On February 18, Judge Baker paused all discovery until the court could organize the litigation.
After an organizational hearing on August 26, Judge Baker signed an initial management order on August 31 appointing leadership for the plaintiffs. Alex C. Davis of Alex Davis Law Office and Randi Kassan of Milberg serve as co-lead counsel, Paul J. James of James & Carter serves as liaison counsel, and a plaintiffs’ steering committee will help run the cases. Sean K. Burke and Dana J. Ash of Duane Morris lead for the defense.
The order asked both sides for position statements by October 1 on how removed implants should be preserved as evidence, whether plaintiffs should use a uniform complaint form, and which related cases are pending in state courts. The court held a follow-up status conference by phone on October 8. No bellwether trial dates have been set. Bellwether trials are early test cases that show how juries respond to the evidence.
The JPML’s October 1 report listed 21 pending cases, the same number as in July. Counts in a new MDL often stay low until the court adopts a simplified complaint form, which can make filing easier for people who have not yet sued.
What the Cartiva Implant Is
The Cartiva implant is a cylinder of polyvinyl alcohol hydrogel, a water-based material meant to act like cartilage. Surgeons press it into a hole drilled in the end of the long bone behind the big toe to treat hallux rigidus, a painful arthritis that stiffens the big toe joint. It was sold as a way to relieve pain while keeping the toe moving, instead of fusing the joint with screws and a plate.
The FDA approved the implant on July 1, 2016, through premarket approval, its strictest review path for medical devices. Approval rested mainly on a company-sponsored study of 202 patients treated in the United Kingdom and Canada. In that study, about 11 percent of Cartiva patients needed a second surgery within two years, close to the rate for patients whose joints were fused.
Wright Medical bought Cartiva, Inc. in October 2018 for $435 million in cash, and Stryker completed its acquisition of Wright Medical in November 2020. The lawsuits name Cartiva, Wright Medical and Stryker entities as defendants.
Why Stryker Recalled the Implant
Stryker began a worldwide recall of every Cartiva implant distributed from July 2016 through October 2024 on October 31, 2024. The FDA posted the recall on December 4, 2024, as a Class II recall, number Z-0598-2025, and listed the cause as device design.
According to the recall notice, recently published data and post-market reports showed patients had a higher-than-expected rate of problems compared with the data submitted for approval. The problems listed include revision or removal surgery, the implant sinking into the bone (called subsidence), the implant shifting or loosening, breaking apart, nerve damage and pain.
The recall covers all four sizes: 6 mm (catalog CAR-06-US), 8 mm (CAR-08-US), 10 mm (CAR-10-US) and 12 mm (CAR-12-US). Patients who are not sure which implant they received can ask their surgeon or request their operative report, which lists the device used. The FDA recall notice has the full product details.
What the Lawsuits Allege
Plaintiffs allege that the hydrogel could not stand up to the force of normal walking. The lawsuits claim the implant loses water, shrinks and hardens over time, then sinks into the surrounding bone, and that a loose or broken implant can trigger inflammation that eats away at the bone around it.
The complaints raise claims of defective design, failure to warn, negligent misrepresentation and breach of warranty. They also allege that the companies knew from post-market reports and published studies that the implant was failing more often than the approval data showed, but did not update the warnings or report the problems to the FDA in time.
Because the implant went through premarket approval, the defense is expected to argue that federal law blocks many state-law injury claims. Plaintiffs respond that claims based on a company’s failure to follow FDA requirements, such as reporting adverse events, can still go forward. The court has not ruled on that question.
When the Implant Fails
People with failed implants report worsening pain in the big toe joint, swelling, stiffness, clicking or grinding, a shortened or misshapen toe, nerve pain, and pain in the ankle, knee, hip or back from walking differently. X-rays or other imaging can show the implant sinking or loosening and the bone around it wearing away.
The usual fix is a fusion surgery to remove the implant and fuse the joint. When the implant has sunk into the bone, surgeons often have to fill the gap with a bone graft before they can fuse the joint with a plate and screws. Recovery typically means weeks off the foot followed by physical therapy, and the result is a permanently stiff toe, the outcome the implant was supposed to avoid.
The lawsuits seek compensation for medical expenses, including the original surgery and any revision surgeries, along with pain and suffering and loss of enjoyment of life. No settlement has been announced. Deadlines to file a lawsuit, called statutes of limitations, vary by state and often run from when a person learned of the injury, so people who have had problems with a Cartiva implant may want to get legal advice promptly.
Common Questions
Is the Cartiva toe implant recalled?
Yes. Stryker recalled every Cartiva Synthetic Cartilage Implant distributed worldwide from July 2016 through October 2024. The FDA classified it as a Class II recall in December 2024 and listed device design as the cause.
Is there a Cartiva class action?
No. The federal Cartiva cases are consolidated in multidistrict litigation, MDL No. 3172, in the Eastern District of Arkansas. Each person keeps an individual lawsuit, and the cases share pretrial proceedings before one judge.
How many Cartiva lawsuits have been filed?
The Judicial Panel on Multidistrict Litigation listed 21 cases pending in MDL No. 3172 as of October 1, 2026. Other cases may be pending in state courts.
What problems are linked to the Cartiva implant?
The recall notice lists revision or removal surgery, the implant sinking into the bone, shifting or loosening, breaking apart, nerve damage and pain. Lawsuits also describe bone loss around the implant.
Has there been a Cartiva settlement?
No. As of late October 2026, no settlement has been announced and no trial dates have been set in the federal litigation.
How do I know if I have a Cartiva implant?
Ask the surgeon who treated your big toe, or request your operative report from the hospital or surgery center. It lists the implant used, including the catalog number.
