BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-0598-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0598-2025
    Event ID
    95661
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cartiva, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 11, 2024
    Initiation Date
    October 31, 2024
    Classification Date
    December 4, 2024
    Address
    6120 Windward Pkwy Ste 220, Alpharetta, GA, 30005-4185, United States

    Description

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

    Reason

    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.

    Code Info

    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.

    Distribution

    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.