Gluteal implants recalled over specification deviations and missing premarket clearance
DSAART is recalling 118 AART Gluteal Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a specification deviation and a premarket clearance shortfall with no stated consequence or reported harm.
Plain-English summary
AART Gluteal Implants from DSAART LLC are being recalled, covering catalog numbers including 501-101 and 501-103 with their corresponding UDI-DI codes.
The recall follows manufactured products that deviated from established specifications and were distributed without obtaining the required FDA premarket approvals or clearances.
The record lists 118 implants, including lot number 24-01-030. Distribution covered Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Florida, Georgia, Kentucky, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas, Utah, Virginia and Washington. The FDA has classified the action as Class II.
The record cites a specification deviation and a clearance shortfall without describing a consequence, and states no injuries. Facilities should follow the firm's instructions.
The recalled product
- Product
- Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal
- Manufacturer
- DSAART LLC
- Affected units
- 118
Distribution
Part of a larger recall action
This product is one of 6 recalled by DSAART LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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