Cartiva Synthetic Cartilage Implant CAR-12-USRecalls & reported problems
Cartiva, Inc · 12 mm Synthetic Cartilage Implant · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00852897002335), received between Dec 30, 2024 and Jun 30, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Implant subsidence” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 31, 2024Class IIOpen, Classified
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.
Z-0598-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Implant subsidence1
Patient problems
- Pain2
- Discomfort1
- Hypersensitivity/Allergic reaction1
- Implant Pain1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE AND REVISED DUE TO PAIN.
Patient problems: Pain
MAUDE report 22362112 ↗InjuryJun 26, 2025Implant subsidence; Implant subsidence
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE. THE PATIENT REVISED 30 MONTHS POST-OPERATION DUE TO PAIN AND SUBSIDENCE.
Patient problems: Pain
MAUDE report 22336701 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLAIMANT, THROUGH COUNSEL, ALLEGES THAT SHE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2020 AND REVISED ON (B)(6) 2023 DUE TO INFECTION AND INFLAMMATORY REACTION.
Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection
MAUDE report 21100104 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS ALLEGED BY A CLAIMANT, THROUGH COUNSEL, THAT HE WAS IMPLANTED WITH CARTIVA ON THE RIGHT SIDE ON (B)(6) 2022 AND WAS REVISED ON (B)(6) 2022 DUE TO HALLUX RIGIDUS WITH PAINFUL CARTIVA IMPLANT GREAT TOE RIGHT FOOT. CLAIMANT DEMANDS COMPENSATION.
Patient problems: Discomfort; Implant Pain; Loss of Range of Motion
MAUDE report 21036661 ↗
Other Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant devices
- Cartiva Synthetic Cartilage Implant CAR-10-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall139 reports
- Cartiva Synthetic Cartilage Implant CAR-08-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall41 reports
- Cartiva Synthetic Cartilage Implant CAR-06-USCartiva, Inc · Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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