Orthofix Srl
Orthofix Srl appears in FDA public data with 65 recalls, 98 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1977-2025, Class II) was initiated on September 24, 2024. Its most recent 510(k) clearance was granted on May 19, 2026.
Summary
- Total Recalls
- 65
- 510(k) Clearances
- 98
- Inspections
- 1
- Compliance Actions
- 0
Known Names
orthofix, orthofix us, orthofix srl
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1977-2025 | Class II | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile | September 24, 2024 |
| Z-0392-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX | September 27, 2018 |
| Z-0390-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX | September 27, 2018 |
| Z-0398-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-93502JP, LOWER LIMB DIAPHYSEAL STERILE KIT (STERILE GAMMA), RX ON | September 27, 2018 |
| Z-0383-2020 | Class II | ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX | September 27, 2018 |
| Z-0402-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054242511533 | September 27, 2018 |
| Z-0379-2020 | Class II | ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile | September 27, 2018 |
| Z-0393-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)1 | September 27, 2018 |
| Z-0391-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-92502, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX | September 27, 2018 |
| Z-0384-2020 | Class II | ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX O | September 27, 2018 |
| Z-0400-2020 | Class II | ORTHOFIX Catalogue Number: ref:99-93503 , ANKLE STERILE KIT, UDI: (01)18033509859922 | September 27, 2018 |
| Z-0401-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT, UDI: (01)1805424251130 | September 27, 2018 |
| Z-0375-2020 | Class II | ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Steril | September 27, 2018 |
| Z-0397-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT, RX ONLY, UDI: (01)180 | September 27, 2018 |
| Z-0381-2020 | Class II | ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONN | September 27, 2018 |
| Z-0373-2020 | Class II | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, | September 27, 2018 |
| Z-0374-2020 | Class II | ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, | September 27, 2018 |
| Z-0399-2020 | Class II | ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KIT, UDI: (01)18054242S51 | September 27, 2018 |
| Z-0382-2020 | Class II | ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNE | September 27, 2018 |
| Z-0377-2020 | Class II | ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Steril | September 27, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | May 8, 2026 |
| K250112 | FitboneTM Trochanteric | April 10, 2025 |
| K242270 | OrthoNext Platform System | December 19, 2024 |
| K242861 | TrueLok Elevate | December 3, 2024 |
| K233867 | Fitbone Trochanteric | June 18, 2024 |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | May 28, 2024 |
| K232648 | RODEO Telescopic Nail | May 3, 2024 |
| K232169 | FITBONE® Transport and Lengthening System | March 22, 2024 |
| K213572 | JuniOrtho Plating System | January 18, 2022 |
| K212044 | TrueLok Evo | November 5, 2021 |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CON | August 31, 2021 |
| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Sy | July 30, 2021 |
| K210157 | SOLE Medial Column Fusion Plate | April 20, 2021 |
| K210667 | FIREBIRD SI Fusion System | March 25, 2021 |
| K203342 | CONSTRUX Mini Ti Spacer System | March 18, 2021 |
| K203576 | FORZA Ti Spacer System | March 3, 2021 |
| K203138 | FIREBIRD SI Fusion System | November 18, 2020 |
| K202949 | CONSTRUX Mini PEEK Spacer System | October 29, 2020 |
| K202519 | OrthoNext Platform System | October 27, 2020 |