Cartiva Implant Recall Issued by Stryker Due to Rising Rates of Big Toe Joint Failure

Manufacturer’s decision to recall Cartiva big toe implants comes as a number of patients pursue lawsuits alleging the device was defectively designed and prone to failure.

Although the Cartiva implant has been widely advertised as a superior alternative to big toe fusion surgery, with the manufacturers claiming patients face a low risk of complications, a massive recall has now been issued for all lots of the synthetic cartilage implant (SCI) sold since July 2016, due to a “higher-than-expected” rate of failure, often resulting in the need for removal or revision surgery.

The Cartiva SCI is a molded cylindrical implant made of polyvinyl alcohol-based hydrogel (PVA), which has been promoted as an alternative to fusion surgery for treating hallux limitus or hallux rigidus, which are forms of degenerative arthritis in the big toe’s first joint.

Although the FDA approved the Cartiva implant in 2016 based on clinical trials showing a 13% failure rate, concerns have emerged in recent years about significantly higher Cartiva failure rates, with a number of individuals now pursuing product liability lawsuits against Stryker, alleging that they manufactured and sold an unreasonably defective and dangerous product.

The Cartiva implant lawsuits outline reports of users experiencing severe complications, including severe toe pain, loosening, fractures and other issues. Often, these complications necessitate surgery to fuse the big toe, resulting in a loss of mobility.

Lawsuits over the Cartiva implant have pointed to a growing body of medical research and case reports published in recent years, which challenged Stryker’s claimed 13% Cartiva failure rate, with some findings suggesting that 79% of Cartiva implants fail within two years.

Earlier this month, a new study was released, which indicated that Cartiva implant patients faced a 30 times higher rate of reoperation than those who received alternative procedures, which was expected to provide important new evidence in the litigation.

Cartiva Implant Recall Issued by Stryker

In response to the growing evidence, Stryker quietly issued a Cartiva implant recall (PDF) late last month, calling for the return of all existing devices, so that it can provide updated postmarket safety information for patients and medical providers.

According to a medical device recall notice sent to surgeons and hospital risk managers on October 31, 2024, Stryker decided to recall Cartiva implants in response to this newly published data and postmarket reports revealing that patients with Cartiva Synthetic Cartilage Implants (SCI) are experiencing higher-than-expected rates of complications compared to the figures presented in the 2016 Premarket Approval (PMA).

These complications include the need for revision or removal of the implant, subsidence, displacement, persistent pain, nerve damage and fragmentation. In several cases, Stryker indicates Cartiva SCI devices have required revision or removal at rates that surpass those observed in the initial premarket and post-approval studies.

The recall includes all lots of Cartiva Synthetic Cartilage Implant (SCI) that were sold from July 2016 through October 2024, including 6 mm, 8 mm, 10 mm and 12 mm sizes, with the following catalog and primary device identifier (PDI) numbers:

• CAR-06-US (6mm) – PDI 00852897002328
• CAR-08-US (8mm) – PDI 00852897002021
• CAR-10-US (10mm) – PDI 00852897002038
• CAR-12-US (12mm) – PDI 00852897002335

Medical facilities are being instructed to review their internal inventories to identify the recalled Cartiva products. Once identified, these devices must be removed from their points of use and either isolated or quarantined to prevent further use. All affected implants available at the facility should be returned to:

Product Field Action Product Return
ATTN: Return PFAA 3775099/PFAE 3794726
Memphis-Arlington Rd
Arlington, TN 38002

As part of the recall, healthcare providers and physicians are instructed to continue monitoring patients who have received the affected Cartiva implants for any new or worsening symptoms. These symptoms may include pain, difficulty walking, skin reactions, stiffness, swelling or weakness in the big toe joint.

If users experience adverse reactions or encounter quality issues with the Cartiva implant, they are encouraged to report these incidents promptly to Stryker’s Trauma & Extremities division complaint department via email and the FDA MedWatch Serious Injury Reporting Program.

Cartiva Implant Failure Lawyers

Lawyers are continuing to investigate new Cartiva implant lawsuits for individuals who have suffered injuries or required additional surgery that could have been avoided if warnings about the rate of Cartiva failures had been disclosed in a timely manner.

Financial compensation may be available through a Cartiva implant failure lawsuit settlement for individuals who received the big toe implant and experienced any of the following complications:

• Implant Failure/Fracture
• Subsidence (implant sinks into the bone)
• Toe Fusion Surgery
• Replacement Surgery
• Revision Surgery

All claims are being pursued by Cartiva implant lawyers on a contingency fee basis, which means that there are no fees or expenses paid unless a Cartiva settlement or lawsuit payout is received.