Calf implants recalled over specification deviations and missing premarket clearance
DSAART is recalling 35 AART Calf 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 Calf Implants from DSAART LLC are being recalled, covering catalog numbers including 502-103, 502-104 and 502-105 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 35 implants, with lot numbers including 23-11-014, 24-07-016 and 25-04-018. 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 Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105
- 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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