FDA-Device2025-12-24Class IIPROCESSING DEFECT
AART Chin Implants recalled for unapproved manufacturing and FDA clearance violations
Stop using AART Chin Implants
DSAART LLC distributed AART Chin Implants that were manufactured with deviations from established specifications and without obtaining required FDA premarket approvals or clearances. The affected implants were distributed across multiple U.S. states.
- If you received an AART Chin Implant (models 400-0101, 400-0103, 400-0104, 400-0201, 400-0202, 400-0301, or 400-0302), contact your healthcare provider immediately.
- Do not use the implant or allow it to be implanted.
- Check the lot number on your implant documentation against the recalled lots listed in the FDA notice.
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Sold states
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
Affected count
29 implants
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2026Don't want to check this manually?
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