Orthofix Srl
VIA DELLE NAZIONI 9, BUSSOLENGO Verona, IT
Registered product codes
34 product codes
Recent MDR events
1,196 on file
- OSCAR PRO UNIVERSAL HANDSETJul 14, 2026Malfunction9680825-2026-00034
- OSCAR PRO UNIVERSAL HANDSETJul 14, 2026Malfunction9680825-2026-00035
- FITBONE TROCHANTERIC NAIL L297MM D9MM STERILEJul 10, 2026Injury9680825-2026-00032
- FITBONE TROCHANTERIC NAIL L297MM D9MM STERILEJul 10, 2026Injury9680825-2026-00033
- FITBONE TRANSPORT NAIL TN 1160-T-350 STERILEJun 30, 2026Malfunction9680825-2026-00031
- FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1160-T-225Jun 26, 2026Injury9680825-2026-00030
- FITBONE SUBCUTANEOUS ENERGY RECEIVERJun 9, 2026Injury2183449-2026-00024
- FITBONE INTRAMEDULLARY LENGTHENING NAIL TAA1180-F-245May 25, 2026Injury9680825-2026-00029
- FITBONE TROCHANTERIC NAIL STERILEMay 15, 2026Injury2183449-2026-00021
- FITBONE SUBCUTANEOUS ENERGY RECEIVERMay 12, 2026Injury9680825-2026-00027
Recalls
36 on file
- Open, ClassifiedJun 13, 2025
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
View FDA record ↗ - TerminatedApr 28, 2010
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
View FDA record ↗ - TerminatedApr 28, 2010
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
View FDA record ↗ - TerminatedUnknown
The power drill torque limiter may break during use in surgery application.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗ - TerminatedUnknown
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
View FDA record ↗
Compliance history
Matched by FEI 3002807827.
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
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.