🔍 RecallPedia

Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

Class I - Dangerous
🏥 Medical Devices Recalled: October 31, 2024 Cartiva Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog/UDI-DI: CAR-06-US/00852897002328, CAR-08-US/00852897002021, CAR-10-US/ 00852897002038, CAR-12-US/00852897002335. All lots Distributed from July 2016 to October 2024.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cartiva, Inc
Reason for Recall:
Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

Product Codes/Lot Numbers:

Catalog/UDI-DI: CAR-06-US/00852897002328, CAR-08-US/00852897002021, CAR-10-US/ 00852897002038, CAR-12-US/00852897002335. All lots Distributed from July 2016 to October 2024.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0598-2025