DSAART LLC: Device Recall
Recall #Z-0949-2026 · 09/26/2025
Recall Details
- Recall Number
- Z-0949-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DSAART LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Carson City, NV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 implants
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Product Description
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
Distribution Pattern
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
Other Recalls by DSAART LLC
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025