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: B4904012025 401-202-6 Malar Implant style 2 size 2

Hazard

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

Details from the source

Reason for recall: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. 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 Quantity: 2 implants Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.