DSAART LLC device recall (Cls II)

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: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing