The Recall Desk

Manufacturer

Orthofix Srl

34 recalls in our database name Orthofix Srl as the manufacturing or recalling firm.

What the numbers show

Total
34
Critical
0
Severe
0
Most recent
2025-06-25

Of the 34 recalls from Orthofix Srl we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–34 of 34

  • ModerateFDA (Devices)·Z-0379-2020·2019-11-20

    Orthofix Drill Bits Recalled for Geometrical Design Defect

    Orthofix Srl is recalling specific batches of 2.7 mm drill bits because a geometrical detail does not match the intended design, which could result in lower cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0403-2020·2019-11-20

    Orthofix Galaxy Wrist Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling Galaxy Wrist Sterile Kits because the drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93601, GALAXY WRIST STERILE KIT, UDI: (01)18054242511656
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0380-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of 8 mm drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0393-2020·2019-11-20

    Orthofix Recalls Prefix II Ankle Kits Due to Drill Bit Design Defect

    Orthofix Srl is recalling specific lots of Prefix II Ankle Complete Kits because drill bits have a geometrical defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0385-2020·2019-11-20

    Orthofix Drill Bits Recalled Due to Geometrical Design Defect

    Orthofix Srl is recalling specific lots of drill bits because a geometrical detail does not match the intended design, potentially reducing cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0400-2020·2019-11-20

    Orthofix Ankle Sterile Kit Drill Bits Recalled for Design Defect

    Orthofix Srl is recalling specific lots of Ankle Sterile Kits because the drill bits have a design defect that may reduce cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0399-2020·2019-11-20

    Orthofix Recalls Tibia Femur Diaphyseal Sterile Kits Due to Design Defect

    Orthofix Srl is recalling Tibia Femur Diaphyseal Sterile Kits because drill bits have a geometrical detail that does not match the intended design, potentially lowering cutting performance.

    Product
    ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2063-2018·2018-06-13

    Orthofix Recalls TL-HEX TruLok Hexapod System Due to Incompatibility

    Orthofix Srl is recalling 408 units of TL-HEX TruLok Hexapod System double row footplates because they are incompatible with current struts, posing a risk of dimensional interference.

    Product
    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0291-2018·2018-01-03

    Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk

    Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.

    Product
    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
    Category
    Medical Device
    Distribution
    3 states