Recall Weekly
Moderate riskFDA DeviceClass II

AART Chin Implants recalled for unapproved manufacturing and FDA clearance violations

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.

From the FDA notice · Read the official notice ↗

What to do

  1. 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.
  2. Do not use the implant or allow it to be implanted.
  3. Check the lot number on your implant documentation against the recalled lots listed in the FDA notice.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
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
Made for
Adults (18 years to 100 years)

This recall covers 6 products — see all of them.

Details

Units affected
29 implants
Illnesses reported
None reported
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Classification
Class II
Recall number
Z-0946-2026

In the FDA's words

Description
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 Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. 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: 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 quantity: 29 implants
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

6 products in this recall

AART silicone implants recalled for lacking FDA approval

DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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