Z-0946-2026Class II

Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1...

Name: Z-0946-2026 Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1...
Creator: Dsaart Llc
Published: 2025-09-26
License: https://open.fda.gov/license/

Dsaart, LLC / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process

FDA source

DSAART LLC began a recall of 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... on 2025-09-26. FDA classified it as Class II and gives the reason as "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0946-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-26
Posted: 2025-12-18
Recalling firm: Dsaart, LLC
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
Product code: FWP Prosthesis, Chin, Internal
Reason for recall: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause tag: manufacturing process
FDA 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 products. 2. Acknowledge their actions via the enclosed "Medical Device Return Response" letter/form. For questions or further assistance with this removal, contact ** or email **.
Quantity in commerce: 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, PR, TX, UT, VA, WA, and WI O.U.S.: N/A
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0946-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0945-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0946-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0947-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0948-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0949-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code FWP

K021417Class IIAart Chin ImplantAesthetic and Reconstructive Technologies, Inc. / cleared 2002-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)