Cartiva, Inc: Device Recall
Recall #Z-0598-2025 · 10/31/2024
Recall Details
- Recall Number
- Z-0598-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Cartiva, Inc
- Status
- Ongoing
- Date Initiated
- 10/31/2024
- Location
- Alpharetta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Product Description
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Distribution Pattern
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.