Class II U.S. Food and Drug Administration

Dsaart LLC Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog recall: Due to manufactured products that deviated from established specifications

Recall published 10 months ago

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0946-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Dsaart LLC
Product type
Medical devices
Units affected
29 implants
Distribution
Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington, Wisconsin
Made in
United States
Lot / code info
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

Products covered by this recall

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

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 24-03-037 — 29 implants

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Dsaart LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: DSAART LLC — 2950 Arrowhead Dr, Carson City, NV, 89706-0488

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Dsaart LLC medical devices recalled?

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 24-03-037 — 29 implants. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland and others.

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