Recall Z-0946-2026 ยท FWP Prosthesis, Chin, Internal
DSAART LLC
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 C
| Date | Dec 18, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| Reason | Manufactured products deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances. |
| Root cause | No Marketing Application |
| Action | On 09/26/2025, the firm emailed a notice to an affected customer informing them that due to identified testing issues, the firm was requesting return of gluteal implants. On 11/17/2025, the firm send an "URGENT Medical Device removal of AART Silicone Implants" Letter to customer informing them that Alpha Aesthetics is voluntarily removing products as they conduct an analysis to determine the regulatory status of the devices. Customers are instructed to: 1. Either return the affected products that have not been implanted to Alpha Aesthetics at the company's expense, or discard affected produc |
| Quantity | 29 implants |
| Distribution | U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, TX, UT, VA, WA, WI and Puerto Rico. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021417 | AART CHIN IMPLANT Aesthetic and Reconstructive Technologies, Inc., Jul 2, 2002 |