Z-0598-2025Class II

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

Name: Z-0598-2025 Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm)...
Creator: Cartiva, Inc
Published: 2024-10-31
License: https://open.fda.gov/license/

Cartiva, Inc. / initiated 2024-10-31 / Open, Classified / root cause: design

FDA source

Cartiva, Inc began a recall of Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm) on 2024-10-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0598-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-31
Posted: 2024-12-04
Recalling firm: Cartiva, Inc.
Product: Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Product code: PNW Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/31/24 recall notices were mailed or emailed to customers asking them to do the following: 1) Continue to follow patients treated with an impacted product for new or worsening symptoms of pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the big toe joint, consistent with your follow up protocols. Per Instructions for Use: the long-term effects of cartilage replacement are not known; and the clinical and medical status of each patient should be considered when treating patients. 2) To help minimize complications, reference the information in the Instructions for Use and the information included in this notification. Per standard practice, continue to discuss all potential risks identified and discuss the benefits and risks of all relevant treatment options for first metatarsophalangeal joint osteoarthritis with your patients. 3) Check your internal inventory to locate the products listed on the attached business reply form, remove them from their point of use, isolate/quarantine the unit(s), and return. 4) Share and maintain awareness of this communication in your practice with until all required actions have been completed within your facility. 5) If you have further distributed the affected product, please notify the applicable parties about this notice. You may copy and distribute this notification letter. 6) If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. 7) If you are a distributor, note that you are responsible for notifying your affected customers. 8) Complete and return the response form via email to [email protected] For questions or concerns, contact [email protected].
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0598-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0598-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-12-04

Product code PNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)