Malar facial implants recalled over specification deviations and missing clearance
DSAART is recalling 2 AART Malar 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 Malar Implants from DSAART LLC are being recalled, covering catalog numbers 401-202-5 (style 2 size 2 left, UDI-DI B4904012025) and 401-202-6 (style 2 size 2 right, UDI-DI B4904012026).
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 2 implants, including lot number 24-01-014. 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 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
- Manufacturer
- DSAART LLC
- Hazard
- specification-deviation
- premarket-clearance
- regulatory
Distribution
Distributed in 27 states:
- AR
- AZ
- CA
- CO
- CT
- DC
- FL
- GA
- IL
- KY
- MA
- MD
- MI
- MN
- MS
- NE
- NJ
- NY
- OH
- OK
- PA
- PR
- TX
- UT
- VA
- WA
- WI
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