Recall Z-0947-2026 ยท LZK Implant, Malar
DSAART LLC
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
| 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 | 2 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
| K021419 | AART MALAR IMPLANT Aesthetic and Reconstructive Technologies, Inc., Jul 2, 2002 |