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 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302

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

Code information: Chin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037

Distribution pattern: 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