Orthofix U.S. LLC
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Known Names
orthofix us, orthofix u.s
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0893-2026 | Class III | Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog | November 3, 2025 |
| Z-0895-2026 | Class III | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38 | November 3, 2025 |
| Z-0891-2026 | Class III | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/ | November 3, 2025 |
| Z-0896-2026 | Class III | Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Ca | November 3, 2025 |
| Z-0892-2026 | Class III | Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: | November 3, 2025 |
| Z-0894-2026 | Class III | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Numb | November 3, 2025 |
| Z-0478-2026 | Class II | Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following si | September 19, 2025 |
| Z-2555-2025 | Class II | PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP | June 24, 2025 |
| Z-1432-2025 | Class II | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade | February 20, 2025 |