Cartiva Implant Lawsuit: The Recalled Toe Implant

The Recall

The Cartiva SCI (Synthetic Cartilage Implant) is a small gel-like device implanted in the big-toe joint to treat arthritis, marketed as an alternative to fusing the joint. In October 2024, Stryker — which had acquired the product line — recalled the implant across all sizes sold since 2016, after real-world results showed complication and failure rates far higher than the figures used to win FDA approval. The reported failures included the implant sinking into the bone (subsidence), fragmenting or shifting, which can cause ongoing pain, limited mobility and the need for revision surgery.

A device pitched as a joint-sparing fix instead left many patients facing a second, more complex operation.

The Litigation

Patients filed lawsuits alleging that the makers — originally Cartiva, then Wright Medical, and now Stryker, which bears the liability — understated the true failure rates to regulators and the public, relied on limited studies that did not reflect real-world outcomes, and failed to warn patients and surgeons as adverse data mounted. The federal cases were consolidated into a multidistrict litigation, with early bellwether trials being prepared. The litigation is active, and there was no global settlement at the time of writing.

Because liability followed the product through corporate acquisitions, the current maker is the defendant even for implants sold under earlier owners.

What Patients Should Know

If you have a Cartiva implant, ask your surgeon whether it falls under the recall and watch for worsening pain, stiffness or a sense that the joint is collapsing, which can signal failure. Keep your surgical records and implant details. If you need revision surgery, preserve the removed device if possible — it can be important evidence — and document your medical course and costs.