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.