Silex Medical, Llc
24 Robert Porter Rd Ste B, SOUTHINGTON, CT, US
Registered product codes
2 product codes
Recent MDR events
1 on file
Recalls
8 on file
- Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗ - Open, ClassifiedJun 2, 2025
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
View FDA record ↗
Compliance history
Matched by FEI 3005110411.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 23, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 23, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 806.10(b)Time to report - 10 days
121 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
121 CFR 820.80(d)Lack of or inadequate final acceptance procedures
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 806.10(b)Apr 23, 2025
Time to report - 10 days
- 21 CFR 820.30(g)Apr 23, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.80(d)Apr 23, 2025
Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Apr 23, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Apr 23, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Apr 23, 2025
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.