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Orthofix, Inc

37 FDA 510(k) clearances · Recalling firm

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◉ Watch Orthofix, Inc

RecordFirmDate
Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFI recall (Z-2116-2018)Orthofix, Inc2018-06-07
Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX recall (Z-2117-2018)Orthofix, Inc2018-06-07
Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 00 recall (Z-2118-2018)Orthofix, Inc2018-06-07
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a recall (Z-2119-2018)Orthofix, Inc2018-06-07
Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part recall (Z-2120-2018)Orthofix, Inc2018-06-07
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size ( recall (Z-2121-2018)Orthofix, Inc2018-06-07
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D recall (Z-2122-2018)Orthofix, Inc2018-06-07
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a recall (Z-2123-2018)Orthofix, Inc2018-06-07
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D recall (Z-2124-2018)Orthofix, Inc2018-06-07
Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM ( recall (Z-2125-2018)Orthofix, Inc2018-06-07
CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small ( recall (Z-2126-2018)Orthofix, Inc2018-06-07
Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM recall (Z-2127-2018)Orthofix, Inc2018-06-07
H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spa recall (Z-2128-2018)Orthofix, Inc2018-06-07
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right ( recall (Z-2129-2018)Orthofix, Inc2018-06-07
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) recall (Z-2130-2018)Orthofix, Inc2018-06-07
MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small recall (Z-2131-2018)Orthofix, Inc2018-06-07
Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) recall (Z-2132-2018)Orthofix, Inc2018-06-07
TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small ( recall (Z-2133-2018)Orthofix, Inc2018-06-07
T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (0 recall (Z-2134-2018)Orthofix, Inc2018-06-07
Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (0 recall (Z-2135-2018)Orthofix, Inc2018-06-07
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, R recall (Z-3127-2017)Orthofix, Inc2017-08-18
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spi recall (Z-1881-2016)Orthofix, Inc2016-06-01
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior recall (Z-0797-2016)Orthofix, Inc2016-02-11
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are use recall (Z-1819-2015)Orthofix, Inc2015-06-19
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant recall (Z-1749-2015)Orthofix, Inc2015-06-10
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nit recall (Z-1089-2014)Orthofix, Inc2014-02-25
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usa recall (Z-0855-2014)Orthofix, Inc.2014-01-28
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD recall (Z-0895-2013)Orthofix, Inc2013-02-28
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector recall (Z-0896-2013)Orthofix, Inc2013-02-28
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Ca recall (Z-1037-2012)Orthofix, Inc.2012-02-15
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Fireb recall (Z-3162-2011)Orthofix, Inc.2011-09-07
BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapp recall (Z-1674-2011)Orthofix Inc2011-03-16
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Par recall (Z-1608-2011)Orthofix Inc2011-03-08
Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: O recall (Z-0590-2011)Orthofix Inc2010-12-10
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Imp recall (Z-0641-2010)Orthofix, Inc2010-01-15
Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device c recall (Z-0262-2010)Orthofix, Inc2009-11-13
Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor, Threaded in recall (Z-0674-2008)Orthofix, Inc2008-02-26

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Every clearance here is in the API, with alerts when new ones post.