Orthofix, Inc

Complete recall history across all FDA and CPSC categories — 30 total recalls

Orthofix, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (30)

FDA medical device enforcement actions by Orthofix, Inc

Date Product Reason Class
Apr 6, 2018 Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Num... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part N... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Pa... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbe... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Le... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx On... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Par... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number)... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Apr 6, 2018 Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx ... Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating Sy... Class II
Feb 23, 2018 ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002 Orthofix is conducting a voluntary recall of the Connector System Large Set S... Class II
Feb 23, 2018 ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 Orthofix is conducting a voluntary recall of the Connector System Large Set S... Class II
Aug 2, 2017 Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, n... The plastic core of the Decorticating Planer was found to be missing, which c... Class II
Apr 27, 2016 Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set scr... There is a possibility that the subject set screw driver could disengage from... Class II
Jan 8, 2016 Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intend... There is a possibility that the device may deliver a torque value less than t... Class II
May 18, 2015 ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Sta... The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping i... Class II
May 11, 2015 ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill G... There is a possibility that the thumb button remains in the depressed (unlock... Class II
Oct 29, 2013 Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Tit... There is a possibility that the locking mechanism of the Azure Anterior Cervi... Class II
Feb 1, 2013 Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial R... There is a possibility that the Set Screw (p/n 90-2923) sub-component of the ... Class II
Aug 6, 2012 Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distra... There is a possibility that the ISKD limb lengthener may stop distracting pos... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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