An Overview of Cartiva Toe Implant Recall and Litigation

Modern science never ceases to amaze, especially with improvements on existing technology. Physicist Michio Kaku illustrates this point very well: in 2011, your cellular telephone had more computing power than the entirety of NASA when it landed men on the moon in 1969. And that annoying little birthday card you get that plays music? The chip inside that card has more computing power than all of the Allied Forces in World War 2. What countries would have gone to war over in 1945 or 1969, we simply throw away, donate to a thrift store or try to sell for 50 cents at a yard sale.

As impressive as this all sounds, we still struggle to mimic what Mother Nature does so easily: the biomechanics of the human body. For example, in 2016, Cartiva, Inc. developed a synthetic cartilage implant (SCI) designed to address pain and reduced range of motion of the first metatarsophalangeal joint (often caused by arthritis). This is the joint where your big toe connects to the rest of your foot.

Unfortunately, the Cartiva SCI failed to meet expectations, which I wrote about last summer. Since publishing that blog post, there have been a few notable developments, including a medical device recall and a number of lawsuits getting close to trial.

The Cartiva Toe Implant Recall

On Halloween of 2024 (coincidence, I hope), Stryker issued a medical device recall of its Cartiva SCI. Stryker didn’t create the artificial cartilage implant, but Stryker acquired the Wright Medical Group NV (Wright) in 2020, and Cartiva, Inc. was a whole owned subsidiary of Wright.

The recall affected 6mm, 8mm, 10mm and 12mm sized implants distributed from July 2016 to October 2024. This amounted to a total recall and withdrawal of all Cartiva SCIs from the market. Stryker stated this recall was due to a higher-than-expected rate of problems with the implant, including the implant coming lose and moving out of place. It’s not fully known why this occurs, but potential reasons include the SCI being too smooth, shrinking, or not being properly held in place due to a weakened bone structure.

The Rise in Cartiva SCI Lawsuits

Even though the recall took place in 2024, problems with the implant had been known well beforehand. Problems with the SCI were being reported in published scientific papers as early as 2022. At least six lawsuits were filed in 2022, although some of these were voluntarily withdrawn without prejudice. “Without prejudice” means the plaintiffs could re-file their lawsuits in the future.

It’s been suspected, but not confirmed, that these cases were close to settlement or that the parties agreed to a tolling agreement. A tolling agreement is where parties to a lawsuit agree to pause the applicable statute of limitations. This can potentially provide more time for each side to negotiate a settlement or obtain more information. Despite these dismissals, more lawsuits were filed in 2024 and 2025, including the following federal cases:

May v. Cartiva, Inc., Case No. 2:24-cv-00687
Krolicki v. Cartiva, Inc., Case No. 1:25-cv-03415
Peachey v. Cartiva, Inc., Case No. 2:25-cv-01217
Hughes v. Cartiva, Inc., Case No. 2:24-cv-00319

At the beginning of 2025, it appeared as if many of these cases would go to trial or settle, but as the year goes on, this seems less likely. For instance, the Hughes case was originally scheduled for an October 28, 2025 trial, although this date was pushed back to May 26, 2026. The May case has also been delayed, with a trial date rescheduled from February 2026 to August 2026.

Allegations Made in Toe Implant Cases

Plaintiffs suing Cartiva, and/or Stryker and Wright have based their claims on one or more of the following causes of action:

Strict product liability
Negligence
Misbranded and adulterated device
Breach of express warranty
Breach of implied warranty
Failure to warn

Notable arguments include Cartiva misrepresenting the failure rates of the SCI, failing to properly study how the implant would perform in humans and failing to warn prospective patients of the risks of receiving this implant.

What’s Next for Cartiva?

Presumably, lawsuits will continue to be filed while a case or two goes to trial or settles. But how long it takes to actually get a trial or settlement is unknown. Then there’s the fact that new cases are consistently getting filed.

If you received a Cartiva SCI and haven’t already done so, talk to your doctor about any problems you might be having. The most common solution for problems with the Cartiva toe implant has been toe fusion surgery. This is where the bones of the big toe are fused together. This can offer pain relief, but could result in a more limited range of motion.

In addition to talking to your doctor, you might want to talk to an attorney. I’m more than happy to set up a consultation, which you can schedule by using the online contact form or calling 919.334.6277 (direct line). Good luck.

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