Cartiva, Inc: Medical Device Recall in 2024 - (Recall #: Z-0598-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 31, 2024

Date Posted: December 11, 2024

Recall Number: Z-0598-2025

Event ID: 95661

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.

Status: Ongoing

Product Quantity:

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated