Recall Z-0598-2025— Cartiva, Inc

Name: FDA recall Z-0598-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-31

Class II · Ongoing

Class II FDA medical device recall by Cartiva, Inc, initiated 2024-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm: Cartiva, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-10-31
Firm location: Alpharetta, GA, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.