Cartiva Synthetic Cartilage Implant — Class II medical device recall Z-0598-2025
Ongoing recall by Cartiva, Inc, reported 2024-12-11, distributed nationwide. Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of
| Recall number | Z-0598-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cartiva, Inc, Alpharetta, GA, United States |
| Recall initiated | 2024-10-31 |
| Classified | 2024-12-04 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BR, CA, CH, CL, CY, DE, ES, FI, FR, GB, HK, IE, IL, IT, KW, LB, LV, NL, NZ, PA, PL, SA, SE, SG, SI |
| UPC / GTIN / UDI-DI | 00852897002021, 00852897002038, 00852897002328, 00852897002335 |
| Model numbers | CAR-06-US |
Product
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0598-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.