FEI 3008110533
Medacta International Sa
Via Alla Rossa 6, Rancate 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 3008110533.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 19, 2024
Compliance: Devices
- No Action Indicated (NAI)Nov 19, 2024
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
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.