Recall Weekly
Moderate riskFDA DeviceClass II

AART Silicone Carving Implants recalled for lacking FDA approval

DSAART LLC distributed AART Silicone Carving Implants without obtaining required FDA premarket approval or clearance, and some products deviated from established manufacturing specifications. These implants are used in augmentation and reconstructive surgery. The FDA has issued a Class II recall affecting 369 implants distributed across multiple U.S. states.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received one of these implants, contact your surgeon immediately
  2. Do not use any AART Silicone Carving Implant with the affected lot numbers listed in the recall
  3. Check your implant documentation for the model number and lot number to confirm if your device is affected
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information
Sold in
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
Made for
Adults (18 years to 100 years)

This recall covers 6 products — see all of them.

Details

Units affected
369 implants
Illnesses reported
None reported
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Classification
Class II
Recall number
Z-0944-2026

In the FDA's words

Description
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. AART Silicone Carving Implant Model/Catalog Number: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 Lot Numbers: 25-01-003 25-01-010 25-01-022 25-02-012 25-03-001 25-04-004 25-05-006 25-05-015 25-06-011 25-06-017 Model/Catalog Number: 600-602 UDI-DI code: B490600602 Lot Numbers: 25-02-006 25-02-021 25-03-007 25-04-005 25-05-017 25-06-015 Model/Catalog Number: 600-601-9 UDI-DI code: B4906006019 Lot Number: 25-02-017 Model/Catalog Number: 600-603-9 UDI-DI code: B4906006039 Lot Number: 25-02-026 Model/Catalog Number: 600-604-9 UDI-DI code: B4906006049 Lot Number: 25-02-018 Model/Catalog Number: 600-602-3-9 UDI-DI code: B49060060239 Lot Number: 24-04-011 Model/Catalog Number: 600-603 UDI-DI code: B490600603 Lot Numbers: 24-11-005 25-01-011 25-02-007 25-02-020 Model/Catalog Number: 600-603-3-9 UDI-DI code: B49060060339 Lot Number: 24-01-013 Model/Catalog Number: 600-604 UDI-DI code: B490600604 Lot Numbers: 24-10-013 25-01-012 25-02-024 25-04-012 Model/Catalog Number: 600-605 UDI-DI code: B490600605 Lot Numbers: 24-05-003 25-01-013 25-06-012 Model/Catalog Number: 600-801 UDI-DI code: B490600801 Lot Numbers: 24-11-017 25-01-004 25-01-014 25-01-023 25-07-009 Model/Catalog Number: 600-803 UDI-DI code: B490600803 Lot Numbers: 24-09-016 25-01-015 Model/Catalog Number: 600-804 UDI-DI code: B490600804 Lot Number: 23-10-005 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 Affected quantity: 369 implants
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

6 products in this recall

AART silicone implants recalled for lacking FDA approval

DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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