medical Class II Updated 2024-12-11

Cartiva, Inc recalls Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US

Recalled Product

Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
View official government recall

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