Orthofix Srl
Orthofix Srl holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2026, with 34 FDA device recalls on record.
Top product codes for Orthofix Srl
FDA recalls by Orthofix Srl
10 most recent of 34- Z-1977-2025 — REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
- Z-0375-2020 — ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867
- Z-0382-2020 — ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075
- Z-0400-2020 — ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922
- Z-0401-2020 — ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)18054242511304
- Z-0373-2020 — ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
- Z-0383-2020 — ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099
- Z-0390-2020 — ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948
- Z-0374-2020 — ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120
- Z-0399-2020 — ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S511298
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 Srl
- K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM
- K253991 — Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
- K250112 — FitboneTM Trochanteric
- K242270 — OrthoNext Platform System
- K242861 — TrueLok Elevate
- K233867 — Fitbone Trochanteric
- K232648 — RODEO Telescopic Nail
- K232169 — FITBONE® Transport and Lengthening System
- K213572 — JuniOrtho Plating System
- K212044 — TrueLok Evo
- K210157 — SOLE Medial Column Fusion Plate
- K202519 — OrthoNext Platform System
- K200246 — JPS JuniOrtho Plating System
- K190388 — RIVAL View Plating Systems and Reduce Fracture Plating Systems
- K180624 — Guided Growth Plate System Plus
- K172699 — Agile Nail
- K172698 — G-Beam Fusion Beaming System
- K172183 — Guided Growth Plate System Plus
- K173458 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
- K173051 — Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
- K170146 — Galaxy UNYCO System
- K170650 — Orthofix TrueLok Hexapod System (TL-HEX) V2.0
- K161466 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
- K153233 — Galaxy UNYCO System
- K152171 — Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
- K143125 — Orthofix True Lok Hexapod System VI.3
- K141760 — ORTHOFIX GALAXY WRIST
- K142052 — ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
- K141571 — ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
- K141078 — ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
- K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
- K113770 — ORTHOFIX GALAXY FIXATION SYSTEM
- K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
- K053261 — ORTHOFIX TITANIUM NAILING SYSTEMS
- K051945 — MIOT PLATING SYSTEM
- K974186 — ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
- K973944 — ORTHOFIX FEMORAL NAILING SYTEM
- K944092 — ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.