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Orthofix, Inc Recalls

14 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Orthofix, Inc.

14Total Recalls
0Critical
7,473Units Affected
Apr 6, 2018Most Recent
All Recalls

Every Orthofix, Inc Recall

Sorted by most recent. Click any recall for full details.

14 recalls
High RiskFDA
Orthofix, Inc
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Medical Devices·50 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
Medical Devices·30 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Medical Devices·100 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-0...
Medical Devices·156 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Lar...
Medical Devices·24 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
Medical Devices·36 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Lar...
Medical Devices·0 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12M...
Medical Devices·1,206 affected·Apr 6, 2018
High RiskFDA
Orthofix, Inc
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Medical Devices·397 affected·Feb 23, 2018
High RiskFDA
Orthofix, Inc
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decor...
Medical Implants·6 affected·Aug 2, 2017
High RiskFDA
Orthofix, Inc
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixa...
Medical Devices·36 affected·Jan 8, 2016
High RiskFDA
Orthofix, Inc
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anter...
Medical Implants·4,172 affected·Oct 29, 2013
High RiskFDA
Orthofix, Inc
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the ...
Medical Devices·1,224 affected·Aug 6, 2012