Orthofix, Inc

FDA Regulatory Profile

Summary

Total Recalls
65
510(k) Clearances
96
Inspections
1
Compliance Actions
0

Known Names

orthofix, orthofix us, orthofix srl

Recent Recalls

NumberClassProductDate
Z-1977-2025Class IIREF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, SterileSeptember 24, 2024
Z-0378-2020Class IIORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non SterileSeptember 27, 2018
Z-0382-2020Class IIORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNESeptember 27, 2018
Z-0392-2020Class IIORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RXSeptember 27, 2018
Z-0379-2020Class IIORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non SterileSeptember 27, 2018
Z-0384-2020Class IIORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX OSeptember 27, 2018
Z-0401-2020Class IIORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)1805424251130September 27, 2018
Z-0391-2020Class IIORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX September 27, 2018
Z-0397-2020Class IIORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)180September 27, 2018
Z-0402-2020Class IIORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533September 27, 2018
Z-0380-2020Class IIORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT,September 27, 2018
Z-0377-2020Class IIORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non SterilSeptember 27, 2018
Z-0395-2020Class IIORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA), RX ONLY, UDI: (01)18September 27, 2018
Z-0389-2020Class IIORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)180329September 27, 2018
Z-0398-2020Class IIORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ONSeptember 27, 2018
Z-0400-2020Class IIORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922September 27, 2018
Z-0373-2020Class IIORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile,September 27, 2018
Z-0393-2020Class IIORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)1September 27, 2018
Z-0381-2020Class IIORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNSeptember 27, 2018
Z-0385-2020Class IIORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX September 27, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250112FitboneTM TrochantericApril 10, 2025
K242270OrthoNext Platform SystemDecember 19, 2024
K242861TrueLok ElevateDecember 3, 2024
K233867Fitbone TrochantericJune 18, 2024
K240749PILLAR SA Ti Spacer System (82-XXX)May 28, 2024
K232648RODEO Telescopic NailMay 3, 2024
K232169FITBONE® Transport and Lengthening SystemMarch 22, 2024
K213572JuniOrtho Plating System™January 18, 2022
K212044TrueLok EvoNovember 5, 2021
K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONAugust 31, 2021
K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation SyJuly 30, 2021
K210157SOLE Medial Column Fusion PlateApril 20, 2021
K210667FIREBIRD SI Fusion SystemMarch 25, 2021
K203342CONSTRUX Mini Ti Spacer SystemMarch 18, 2021
K203576FORZA Ti Spacer SystemMarch 3, 2021
K203138FIREBIRD SI Fusion SystemNovember 18, 2020
K202949CONSTRUX Mini PEEK Spacer SystemOctober 29, 2020
K202519OrthoNext Platform SystemOctober 27, 2020
K202666CONSTRUX Mini PTC Spacer SystemOctober 14, 2020
K201664FIREBIRD SI Fusion SystemSeptember 15, 2020