Cartiva® Implant Recall: What Patients Should Know
The manufacturer initiated a recall involving Cartiva® Synthetic Cartilage Implants after identifying higher-than-expected rates of certain complications. The recall includes listed Cartiva® implants distributed from July 2016 through October 2024.
Understanding the recall, possible complications, and your treatment history can help you decide what steps to take next.
WHY WERE CARTIVA® IMPLANTS RECALLED?
According to the FDA recall record, patients with Cartiva® implants may experience higher-than-expected rates of:
- Revision surgery
- Implant removal
- Implant subsidence or sinking
- Implant displacement
- Persistent or worsening pain
- Nerve damage
- Implant fragmentation
The FDA recall database identifies the determined cause as “Device Design.” According to the FDA, recall-cause determinations may be modified before a recall is terminated.
THE CARTIVA® RECALL TIMELINE
July 1, 2016
FDA Approval
The FDA approved the Cartiva® Synthetic Cartilage Implant for use in certain patients with painful degenerative or post-traumatic arthritis in the joint at the base of the big toe.
July 2016 Through October 2024
Affected Distribution Period
The recall covers all listed Cartiva® implant sizes and lots distributed during this period.
October 31, 2024
Recall Initiated
The manufacturer initiated the recall and sent notices to affected customers.
December 4, 2024
Recall Posted by the FDA
The FDA posted the recall in its medical-device recall database and classified it as a Class II device recall.
WHAT TO DO IF YOU RECEIVED A CARTIVA® IMPLANT
- Continue receiving appropriate medical care
- Speak with your doctor about new or worsening symptoms
- Locate your implant card, if available
- Request your operative report or surgical records
- Write down when your symptoms began
- Keep records of follow-up appointments and treatment
- Document any effect on walking, mobility, work, or daily activities
- Find out whether your situation meets the current claim-screening criteria
The manufacturer’s recall notice advised healthcare providers to monitor affected patients for new or worsening pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the big-toe joint.
Do not discontinue treatment or delay medical care based on information provided by this website.
WHY THE RECALL MAY MATTER TO A LEGAL CLAIM
The recall may provide relevant information about the Cartiva® implant, the products included, their distribution dates, and the complications identified by the manufacturer.
A potential claim may also require information about:
- The type of implant you received
- When and where the implant was placed
- The complications you experienced
- Your medical and surgical records
- Follow-up treatment or recommended procedures
- The state where you received treatment
- Applicable legal filing deadlines
A recall does not automatically establish that an implant caused a particular injury. It also does not guarantee that a legal claim will be accepted or that compensation will be recovered. Each situation must be evaluated individually.
Were You Affected by the Cartiva® Implant Recall?
If you received a Cartiva® big-toe implant between July 1, 2016 and October 31, 2024 and experienced complications, you may qualify for a free case review.
Revision surgery, implant removal, or toe-fusion surgery is not required to request a review.
FAQ
Why was the Cartiva® implant recalled?
According to the FDA recall record, patients implanted with the device may experience higher-than-expected rates of revision, implant removal, subsidence, displacement, pain, nerve damage, or fragmentation.
Which Cartiva® implants are included?
The FDA recall record lists the 6 mm, 8 mm, 10 mm, and 12 mm Cartiva® Synthetic Cartilage Implants. It covers all lots distributed from July 2016 through October 2024.
How can I confirm that I received a Cartiva® implant?
Your implant card, operative report, hospital records, medical bills, or surgeon’s records may identify the device used during your procedure.
What symptoms were identified in the recall notice?
Healthcare providers were advised to monitor patients for new or worsening pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the big-toe joint.
Check If the Cartiva® Recall May Apply to You
Answer a few questions about your implant date, complications, treatment, and current legal representation.