DSAART LLC: 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
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- DSAART LLC
- 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
- Reason / hazard
- Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2025-09-26
- Code info
- 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
- Product quantity
- 2 implants
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Carson City
- State
- NV
- Country
- United States
- Event id
- 97704
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