FDA-Device2025-12-24Class IIMISBRANDING
AART Calf Implants recalled for unapproved distribution and specification deviations
What this means
DSAART LLC distributed calf implants that did not meet FDA requirements. The products were sold without required FDA premarket approval or clearance, and some deviated from manufacturing specifications. Approximately 35 implants were distributed across multiple U.S. states.
- Stop using your AART Calf Implant immediately
- Contact your surgeon or healthcare provider to discuss removal or replacement options
- Check the model number and lot number on your implant documentation against the FDA recall list
The agency's original wording
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
35 implants
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2026Want us to check the next one for you?
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