The Recall Desk

Manufacturer

Orthofix, Inc.

31 recalls in our database name Orthofix, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
31
Critical
0
Severe
12
Most recent
2018-06-13

Of the 31 recalls from Orthofix, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (39%) 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.

26–31 of 31

  • HighFDA (Devices)·Z-1819-2015·2015-07-01

    Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk

    Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.

    Product
    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1749-2015·2015-06-17

    Orthofix Firebird Spinal Fixation System Recalled for Mislabeling

    Orthofix is recalling Firebird Spinal Fixation System screws because the length marking on the tip is incorrect.

    Product
    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1089-2014·2014-03-05

    Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk

    Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.

    Product
    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2014·2014-02-05

    Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction

    Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.

    Product
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0896-2013·2013-03-06

    Orthofix Firebird Spinal Fixation System Rod Connectors Recalled for Cracking Risk

    Orthofix is recalling Firebird Spinal Fixation System rod connectors because a sub-component may crack during tightening.

    Product
    Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2013·2013-03-06

    Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure

    Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.

    Product
    Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Orthofix

public company

Founded
1980

Official website

Source: Wikidata (Q1116464), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.