In October 2024, Stryker issued a voluntary recall of the Cartiva Synthetic Cartilage Implant, a medical device that had been marketed since 2016 as an alternative to fusion surgery for patients with big toe arthritis. Federal litigation has since been consolidated to address claims brought by patients who experienced implant failure and its consequences.
This post explains what the Cartiva SCI is, why it was recalled, what the litigation involves, and what factors may be relevant to patients who received the device.
What Is the Cartiva SCI?
The Cartiva Synthetic Cartilage Implant is a small, bullet-shaped device made from a polyvinyl alcohol (PVA) hydrogel material — essentially a synthetic gel designed to mimic the cushioning function of natural cartilage. It was implanted directly into the joint at the base of the big toe as a treatment for hallux rigidus, a painful form of big toe arthritis that causes stiffness and difficulty walking
Cartiva, Inc. marketed the SCI heavily as a revolutionary alternative to the traditional surgical solution for big toe arthritis — a bone fusion procedure that, while effective at reducing pain, permanently eliminates movement in the joint. The promise of the SCI was straightforward and appealing: pain relief without sacrificing motion, marketed to active patients as a path back to running, walking, and an unrestricted life.
What Went Wrong?
The FDA approved the Cartiva SCI in 2016, based primarily on a single clinical trial involving just 202 patients conducted entirely in the United Kingdom and Canada. That study reported a failure rate of approximately 13.5 percent over a two-year follow-up period.
As the device entered widespread use in the United States, a very different picture emerged. Independent clinical studies documented real-world failure rates of 50 to 64 percent — four to six times higher than what the manufacturer reported to the FDA. Surgeons who had been among the device’s earliest adopters, including physicians who had personally trained others in its use, quietly stopped offering it after seeing failure rates in their own practices that far exceeded anything the manufacturer had represented.
The core failure mechanism is a process called subsidence: the PVA material degrades and shrinks over time, causing the implant to loosen and migrate from its original position. As it moves, it can erode surrounding bone, trigger inflammatory reactions, and cause severe, worsening pain. Many patients who received the SCI hoping to avoid a fusion ultimately required that exact surgery anyway — often in worse condition than if they had chosen fusion from the start.
The Recall and Federal Litigation
On October 31, 2024, Stryker — which acquired Wright Medical Group in 2020 for approximately $4.7 billion, thereby assuming ownership and liability for the Cartiva product line — issued a voluntary Class II recall of all Cartiva SCI devices distributed since July 2016. The FDA’s adverse event database now contains more than 400 reports linked to the device, the majority involving implant loosening or failure.
On February 5, 2026, the U.S. Judicial Panel on Multidistrict Litigation centralized federal Cartiva lawsuits into MDL No. 3172, formally titled In re: Cartiva Synthetic Cartilage Implant Products Liability Litigation, assigned to Judge Kristine G. Baker in the Eastern District of Arkansas. Our firm is actively filing cases into this MDL on behalf of patients harmed by the device.
Factors Relevant to Potential Claims
Patients who received the Cartiva SCI and subsequently experienced one or more of the following may have grounds for a legal claim:
- Persistent or worsening pain following implant surgery
- Implant loosening, migration, or failure
- Revision surgery to remove or replace the implant
- Fusion surgery (the outcome the SCI was supposed to prevent)
- Infection, bone loss, or nerve damage related to the device
Statutes of limitations vary by state and by individual circumstance. The October 2024 recall is a significant date in the limitations analysis for many patients, as it is the point at which the defect was publicly acknowledged. Patients who are considering whether to pursue a claim are encouraged to consult with counsel promptly.
Contact Us
Cline Donaldson PLLC is a litigation firm based in Wilmington, North Carolina, representing individuals in complex personal injury and product liability matters. We are actively reviewing Cartiva SCI cases and would welcome the opportunity to speak with you about your situation.
Thomas R. Harvey III
Cline Donaldson PLLC
5725 Oleander Drive, Suite G-3, Wilmington, NC 28403
(910) 679-6799
This blog post is for informational purposes only and does not constitute legal advice. Reading this post does not create an attorney-client relationship. If you believe you have a legal claim, please consult with a qualified attorney.
