BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 31, 2024

    Recall

    Recall Number
    Z-0598-2025
    Event Number
    95661
    Firm
    Cartiva, Inc
    FEI Number
    3009351138
    Product Code
    PNW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 31, 2024
    Posted
    December 4, 2024
    Address
    6120 Windward Pkwy, Ste 220, Alpharetta, GA, 30005-4185

    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.

    Action

    On 10/31/24 recall notices were mailed or emailed to customers asking them to do the following: 1) Continue to follow patients treated with an impacted product for new or worsening symptoms of pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the big toe joint, consistent with your follow up protocols. Per Instructions for Use: the long-term effects of cartilage replacement are not known; and the clinical and medical status of each patient should be considered when treating patients. 2) To help minimize complications, reference the information in the Instructions for Use and the information included in this notification. Per standard practice, continue to discuss all potential risks identified and discuss the benefits and risks of all relevant treatment options for first metatarsophalangeal joint osteoarthritis with your patients. 3) Check your internal inventory to locate the products listed on the attached business reply form, remove them from their point of use, isolate/quarantine the unit(s), and return. 4) Share and maintain awareness of this communication in your practice with until all required actions have been completed within your facility. 5) If you have further distributed the affected product, please notify the applicable parties about this notice. You may copy and distribute this notification letter. 6) If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. 7) If you are a distributor, note that you are responsible for notifying your affected customers. 8) Complete and return the response form via email to [email protected] For questions or concerns, contact [email protected].

    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.