Chin implants recalled over specification deviations and missing premarket clearance
DSAART is recalling 29 AART Chin Implants because the products deviated from established specifications and were distributed without the required FDA premarket approvals or clearances.
- Product
- Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 40
- Category
- Medical Device
- Distribution
- 27 states