Orthofix, Inc.
Orthofix, Inc. holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2024, with 31 FDA device recalls on record.
Top product codes for Orthofix, Inc.
FDA recalls by Orthofix, Inc.
10 most recent of 31- Z-2130-2018 — 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)
- Z-2131-2018 — 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) Large (002-B-03003)
- Z-2126-2018 — 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) Large (002-G-01030)
- Z-2123-2018 — 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 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)
- Z-2124-2018 — Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)
- Z-2132-2018 — Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
- Z-2122-2018 — Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-27018); g) D 2.7MM X 20MM (002-E-27020); h) D 2.7MM X 22MM (002-E-27022); i) D 2.7MM X 24MM (002-E-27024); j) D 2.7MM X 26MM (002-E-27026); k) D 2.7MM X 28MM (002-E-27028); l) D 2.7MM X 30MM (002-E-27030); m) D 2.7MM X 32MM (002-E-27032); n) D 2.7MM X 34MM (002-E-27034); o) D 2.7MM X 36MM (002-E-27036); p) D 2.7MM X 38MM (002-E-27038); q) D 2.7MM X 40MM (002-E-27040)
- Z-2135-2018 — 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)
- Z-2117-2018 — 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
- Z-2119-2018 — Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-20030)
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Orthofix, Inc.
- K240749 — PILLAR SA Ti Spacer System (82-XXX)
- K211704 — CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System
- K211710 — Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
- K210667 — FIREBIRD SI Fusion System
- K203342 — CONSTRUX Mini Ti Spacer System
- K203576 — FORZA Ti Spacer System
- K203138 — FIREBIRD SI Fusion System
- K202949 — CONSTRUX Mini PEEK Spacer System
- K202666 — CONSTRUX Mini PTC Spacer System
- K201664 — FIREBIRD SI Fusion System
- K201481 — Centurion POCT System
- K200606 — O-Genesis Graft Delivery System
- K200052 — CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
- K200696 — FIREBIRD SI Fusion System
- K190751 — Connector System
- K183342 — SambaScrew 3D SI Fusion System
- K180179 — Firebird® Spinal Fixation Systems: Firebird System +6 more
- K172115 — Navigated Instrument System
- K180025 — Centurion POCT System
- K172696 — FORZA® XP Expandable Spacer System
- K172437 — CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
- K172194 — Connector System
- K170647 — Connector System
- K171082 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
- K162921 — Navigated Instrument System
- K162446 — FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System
- K162638 — CETRA Anterior Cervical Plate System
- K161129 — PILLAR SA PTC
- K161280 — Cervical Stand Alone System
- K153428 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
- K152475 — FORZA PTC Spacer System
- K150619 — CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
- K151488 — Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
- K143028 — Azure Anterior Cervical Plate System
- K150822 — Centurion POCT System
- K142152 — CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
- K141186 — FIREBIRD SPINAL FIXATION SYSTEM
- K140260 — SKYHAWK LATERAL PLATE SYSTEM
- K140709 — SKYHAWK INTERBODY FUSION SYSTEM
- K132999 — CERVICAL STAND ALONE SYSTEM
- K131833 — CENTURION POCT SYSTEM
- K130932 — FIREBIRD SPINAL FIXATION SYSTEM
- K130825 — AZURE ANTERIOR CERVICAL PLATE SYSTEM
- K121658 — ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
- K111448 — ICON (TM) MODULAR PEDICLE SCREW SYSTEM
- K110805 — GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
- K111183 — ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS)
- K103111 — FORZA SPACER SYSTEM
- K102201 — CONTOURS LAPIDUS PLATING SYSTEM
- K101936 — CONTOURS VSP III VOLAR PLATING SYSTEM
- K101812 — CONSTRUX MINI PEEK SPACER SYSTEM
- K093442 — GUIDED GROWTH SYSTEM
- K042766 — ORTHOFIX VOLAR DISTAL RADIAL PLATE
- K031219 — MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
- K970400 — BONE SOURCE HYDROXYAPATITE
- K961027 — ORTHOFIX TIBIAL NAILING SYSTEM
- K955848 — ORTHOFIX MODULSYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.