Reported Dec 11, 2024 · Ongoing
Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
Cartiva, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cartiva, Inc · 6120 Windward Pkwy Ste 220 · Alpharetta, GA · 30005-4185
Is this the product you have?
- Cartiva Synthetic
- Cartilage Implant (SCI) Catalog
CAR-06-US (6mm)CAR-08-US (8mm)CAR-10-US (10mm)CAR-12-US (12mm)
- Lot codes and dates
- Catalog/UDI-DICAR-06-US/00852897002328, CAR-08-US/00852897002021, CAR-10-US/ 00852897002038, CAR-12-US/00852897002335. All lots Distributed from July 2016 to October 2024
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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