AART Malar Implant recalled for lack of FDA approval and specification deviations
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- 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
- Made for
- Adults (0 months and older)
This recall covers 6 products — see all of them.
Details
- Units affected
- 2 implants
- Illnesses reported
- None reported
- Manufactured in
- 2950 Arrowhead Dr, Carson City, NV, United States
- Classification
- Class II
- Recall number
- Z-0947-2026
In the FDA's words
- Description
- 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 Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015 Distribution: 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 quantity: 2 implants
- Hazard
- Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
6 products in this recall
AART silicone implants recalled for lacking FDA approval
DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI…Z-0944-2026 · 369 implants
- Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101…Z-0945-2026 · 118 implants
- Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103…Z-0946-2026 · 29 implants
- 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… (this page)Z-0947-2026 · 2 implants
- Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B49050…Z-0948-2026 · 41 implants
- Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 -…Z-0949-2026 · 35 implants