FDA Device recall 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)
- FDA Device
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm) by Cartiva, citing patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0598-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-31 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cartiva |
| Distribution | 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
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.
Identifiers
| code_info | Catalog/UDI-DI: CAR-06-US/00852897002328, CAR-08-US/00852897002021, CAR-10-US/ 00852897002038, CAR-12-US/00852897002335…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2025%22
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