Is Your Cartiva Toe Implant Part of the Recall?

How can I tell if my Cartiva implant is in the recall?

Find the sticker or implant record from your toe surgery. The recall lists one catalog number and one device code for each of four sizes. It covers every lot of those sizes shipped from July 2016 to October 2024.

The four U.S. catalog numbers are CAR-06-US (6 mm), CAR-08-US (8 mm), CAR-10-US (10 mm) and CAR-12-US (12 mm). Each has its own device code, called a UDI-DI. For example, the 6 mm code is 00852897002328.

You can type the code from your sticker into AccessGUDID, a free public FDA and National Library of Medicine database. It shows the size and catalog number the code belongs to. It lists all four sizes as no longer sold, with sales ending on October 17, 2024.

The first approval in 2016 was for the 8 mm and 10 mm sizes. FDA approved the 6 mm and 12 mm sizes on July 11, 2019.

Does the recall cover implants put in outside the U.S.?

The FDA record says the implants were shipped across the U.S. and to many other countries. Canada posted its own recall of the implant in November 2024. Its notice covers all lots of the sizes sold there.

The countries in the FDA record include Canada, Australia, the United Kingdom, Germany, France and Israel. Canada’s notice lists its own catalog numbers: CAR-06, CAR-08, CAR-10 and CMC-08.

Why was the Cartiva implant recalled in 2024?

The company said patients may have more problems than expected. Canada’s notice says that, in some cases, implants were redone or taken out more often than in the studies for approval. FDA names the cause as the design.

Canada’s notice says Stryker learned of this from recently published data and reports from use after approval. It compared those to the data sent to FDA for the 2016 approval.

FDA says the cause it names can still change until the recall is closed. The record does not say how many implants were sold.

What did the follow-up study FDA required show?

As a condition of approval, FDA told Cartiva to follow the first trial’s patients for five years. The study was finished in 2018. Of the trial implants still in place at two years, FDA’s summary says 7.6% were removed by year five.

That study met its goal, which was set against an expected removal rate of 13.5%. FDA’s summary reports no unexpected safety concerns up to five years. In July 2019, FDA approved a label change to add the study results.

The study only followed patients from the original trial, at 12 sites. So it does not show how implants did for people treated after approval. The 2024 recall notices point to later data.

Does the recall mean my implant has to come out?

Not by itself. The recall did not ask for implants to be taken out. It told hospitals to set aside and return unused ones, and asked surgeons to keep checking on patients. Talk to your surgeon before any choice about your implant.

FDA says a recalled implant does not always have to be taken out. The notice also repeats a warning from the implant’s label: the long-term effects of replacing cartilage are not known.

Is the Cartiva recall still open?

Yes. When we checked on October 5, 2026, FDA still listed it as open. Open means the company started the recall and not all products have been fixed or removed.

The company started the recall on its own, and FDA classed it on December 4, 2024. It is the only recall FDA lists under the implant’s approval number, P150017. FDA closes a recall only once it is sure the product no longer poses a health risk.