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.
- 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
- Category
- Medical Device
- Distribution
- 27 states