I.t.s. Gmbh
AUTAL 28, LASSNITZHOEHE Steiermark, AT
Registered product codes
13 product codes
Recent MDR events
193 on file
- CORTICAL STABILIZATION SCREWJul 14, 2026Injury3004369035-2026-00404
- FLS PLATE, H-SHAPEJul 14, 2026Injury3004369035-2026-00401
- CORTICAL STABILIZATION SCREWJul 14, 2026Injury3004369035-2026-00402
- CORTICAL STABILIZATION SCREWJul 14, 2026Injury3004369035-2026-00403
- PF NAIL 130°, INTERMEDIATE, LEFT, Ø10X240MM, PPSJul 2, 2026Injury3004369035-2026-00310
- PF SET SCREW, STANDARD, L=120MM, PPSJul 2, 2026Injury3004369035-2026-00320
- CLAVICLE PLATE 3.5MMMay 12, 2026Malfunction3004369035-2026-00002
- CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MMApr 8, 2026Malfunction3004369035-2026-00101
- CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MMApr 8, 2026Malfunction3004369035-2026-00102
- RADIUS PLATE PROLOCK IISep 8, 2025Malfunction3004369035-2025-00041
Recalls
18 on file
- Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedMar 20, 2026
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
View FDA record ↗
Compliance history
Matched by FEI 3004369035.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.