Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates
Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical implant with multiple serious potential complications including nerve damage, implant displacement, and fragmentation. The source indicates these complications occur at higher-than-expected rates, but does not provide specific injury or hospitalization counts, keeping this at High rather than Severe.
Plain-English summary
Cartiva, Inc. is recalling all Cartiva Synthetic Cartilage Implants (available in 6mm, 8mm, 10mm, and 12mm catalog sizes) due to a higher-than-expected occurrence of serious complications. Reported hazards include implant subsidence (sinking), displacement, fragmentation, revision surgery requirements, implant removal, pain, and nerve damage.
The affected implants were distributed worldwide and throughout the United States from July 2016 to October 2024, reaching numerous states and international countries. The recall affects patients who received these implants during this distribution period.
Patients who have received these implants should contact their surgeon or healthcare provider immediately to discuss their individual situation. Healthcare providers should review patient records to identify affected recipients and determine appropriate follow-up care. This is a Class II recall issued by the FDA.
The recalled product
- Product
- Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
- Manufacturer
- Cartiva, Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
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