This recall affects all lots of the Cartiva Synthetic Cartilage Implant (SCI) distributed between July 2016 and October 2024. These surgical implants, used in the big toe, are being recalled because they have shown a higher-than-expected rate of failure. Reported issues include the implant sinking into the bone, moving out of place, or breaking apart, which often requires a second surgery to fix or remove the device.
Patients may experience severe pain, nerve damage, or the need for additional surgeries if the implant fails, sinks, or fragments within the joint. There have been reports of implant displacement and subsidence necessitating removal or revision surgery.
Recall #: Z-0598-2025
Recall #: Z-0598-2025
Recall #: Z-0598-2025
Recall #: Z-0598-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.