FEI 3005180920
Medacta International Sa
Strada Regina, Castel San Pietro Ticino, CH
MDR events12,671All time
Recalls0All time
Registered products109
Establishment typeComplaintComplaint File Establishment per 21 CFR 820.198
Registered product codes
109 product codes
Recent MDR events
12,671 on file
- Knee InstrumentsJul 27, 2026Malfunction3005180920-2026-00767
- GMK Hinge Total Knee SystemJul 27, 2026Injury3005180920-2026-00780
- Mectacer Biolox Delta Femoral Ball HeadJul 27, 2026Injury3005180920-2026-00792
- Mectacer Biolox Delta Femoral Ball HeadJul 27, 2026Injury3005180920-2026-00768
- AMIStem H Femoral StemsJul 27, 2026Injury3005180920-2026-00795
- Quadra H femoral stemsJul 27, 2026Injury3005180920-2026-00742
- SMS StemJul 27, 2026Injury3005180920-2026-00789
- GMK Sphere Total Knee SystemJul 27, 2026Injury3005180920-2026-00784
- GMK Sphere Total Knee SystemJul 27, 2026Injury3005180920-2026-00757
- GMK Hinge Total Knee SystemJul 27, 2026Injury3005180920-2026-00748
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3005180920.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 19, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 19, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.198(a)Nov 19, 2024
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.