DSAART LLC: Device Recall
Recall #Z-0946-2026 · 09/26/2025
Recall Details
- Recall Number
- Z-0946-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DSAART LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Carson City, NV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 implants
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Product 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
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
Other Recalls by DSAART LLC
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025