Orthofix, Inc
Lewisville, TX
This page shows every FDA and USDA recall linked to Orthofix, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
36
Total Recalls
2010
First Recall
2018
Most Recent
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Me...
Jun 7, 2018
· Device
Terminated
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L)...
Jun 7, 2018
· Device
Terminated
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Larg...
Jun 7, 2018
· Device
Terminated
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on labe...
Jun 7, 2018
· Device
Terminated
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (000...
Jun 7, 2018
· Device
Terminated
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on la...
Jun 7, 2018
· Device
Terminated
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-2...
Jun 7, 2018
· Device
Terminated
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-...
Jun 7, 2018
· Device
Terminated
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002...
Jun 7, 2018
· Device
Terminated
Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001);
b) 22M...
Jun 7, 2018
· Device
Terminated
Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001)...
Jun 7, 2018
· Device
Terminated
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number):
a) Sm...
Jun 7, 2018
· Device
Terminated
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Lar...
Jun 7, 2018
· Device
Terminated
H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);...
Jun 7, 2018
· Device
Terminated
Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006...
Jun 7, 2018
· Device
Terminated
TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Med...
Jun 7, 2018
· Device
Terminated
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D...
Jun 7, 2018
· Device
Terminated
Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
Jun 7, 2018
· Device
Terminated
Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM...
Jun 7, 2018
· Device
Terminated
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020);
b) Med...
Jun 7, 2018
· Device
Terminated
ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003
Feb 23, 2018
· Device
Terminated
ORTHOFIX, Connector System, LARGE SET SCREW, REF 79-2002
Feb 23, 2018
· Device
Terminated
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx.
.A Decorticati...
Aug 18, 2017
· Device
Terminated
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation constru...
Jun 1, 2016
· Device
Terminated
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)
Intended for posterior, non-cervical pedi...
Feb 11, 2016
· Device
Terminated
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with...
Jun 19, 2015
· Device
Terminated
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Allo...
Jun 10, 2015
· Device
Terminated
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc.,...
Feb 25, 2014
· Device
Terminated
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver,
Product Usage: The Modular...
Jan 28, 2014
· Device
Terminated
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700).
Produc...
Feb 28, 2013
· Device
Terminated
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor.
The ISKD is intended for...
Feb 28, 2013
· Device
Terminated
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-045...
Feb 15, 2012
· Device
Terminated
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation...
Sep 7, 2011
· Device
Terminated
BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BL...
Mar 16, 2011
· Device
Terminated
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #165...
Mar 8, 2011
· Device
Terminated
Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Br...
Dec 10, 2010
· Device
Terminated