DSAART LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
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 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304
Calf Implant Model/Catalog Number: 502-103 UDI-DI code: B490502103 Lot Numbers: 23-11-014 24-07-016 25-04-018 Model/Catalog Number: 502-104 UDI-DI code: B490502104 Lot Numbers: 24-02-011 24-07-017 25-04-003 Model/Catalog Number: 502-105 UDI-DI code: B490502105 Lot Number: 24-05-019 Model/Catalog Number: 502-106 UDI-DI code: B490502106 Lot Numbers: 24-09-006 24-12-011 Model/Catalog Number: 502-201 UDI-DI code: B490502201 Lot Number: 24-01-001 Model/Catalog Number: 502-303 UDI-DI code: B490502303 Lot Number: 23-06-019 Model/Catalog Number: 502-304 UDI-DI code: B490502304 Lot Numbers: 24-12-013 25-03-005
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →