FDA-Device2025-12-24Class IIMISBRANDING
AART Malar Implant recalled for lack of FDA approval and specification deviations
What this means
DSAART LLC distributed AART Malar Implants (model 401-202-5 and 401-202-6, lot numbers 24-01-014 and 24-01-015) without obtaining required FDA premarket approval and with deviations from established manufacturing specifications. Two implants were affected and distributed across multiple U.S. states.
- If you received one of these implants, contact your surgeon or healthcare provider immediately.
- Do not use this product.
- Report any complications or injuries to the FDA MedWatch program at 1-888-SAFEFDA or online at fda.gov/medwatch.
The agency's original wording
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A
Affected count
2 implants
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Products
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2026Want us to check the next one for you?
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