FDAFDA · Food and drugs·Recall number Z-0598-2025
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Published December 11, 2024 · Recall initiated: October 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Cartiva, Inc
- Distributor
- Worldwide - US Nationwide distribution in the states of CO, CT, FL, IL, MI, MS, NY, OH, RI, UT, VA, AL, AR, AZ, CA, IA, ID, IN, KS, KY, MA, MN, MO, MT, NC, NE, NM, NV, OK, OR, PA, TN, TX, WA, WI and the countries of Australia, Austria, Brazil, Canada, Chile, Cyprus, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Netherlands, New Zealand, Panama, Poland, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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