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DSAART LLC recalls Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1
Recalled December 24, 2025 · FDA recall Z-0946-2026 · DSAART
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. · FDA Class II
Units
29 implants
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
Description
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Product
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
Manufacturer(s)
DSAART LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →