Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Reported: December 11, 2024 Initiated: October 31, 2024 #Z-0598-2025
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.
Details
- Recalling Firm
- Cartiva, Inc
- 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.
- Location
- Alpharetta, GA
Frequently Asked Questions
What product was recalled? ▼
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm). Recalled by Cartiva, Inc.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0598-2025.
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