Orthofix Srl
FDA adverse event reports naming Orthofix Srl as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ORTHOFIX SRL.
- Total reports
- 1,166
- Deaths
- 2
- Injuries
- 819
- Malfunctions
- 328
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Rod, Fixation, Intramedullary And AccessoriesHSB268
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentKTT262
- Pin, Fixation, ThreadedJDW244
- Component, Traction, InvasiveJEC104
- Instrument, Surgical, Sonic And Accessory/AttachmentJDX94
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeLXT71
- Screw, Fixation, BoneHWC42
- Plate, Fixation, BoneHRS35
- Device, Fixation, Proximal Femoral, ImplantJDO13
- Nail, Fixation, BoneJDS8
Recent recalls
- 2025-06-13Open, ClassifiedUse error
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
- 2010-04-28TerminatedNonconforming Material/Component
Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
- 2010-04-28TerminatedNonconforming Material/Component
Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
- TerminatedProcess change control
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
The power drill torque limiter may break during use in surgery application.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
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.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
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.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
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.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
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.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911
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.
- TerminatedDevice Design
ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966
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.
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