Orthofix U.S. LLC
Orthofix U.S. LLC appears in FDA public data with 13 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2729-2026, Class II) was initiated on June 10, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2729-2026 | Class II | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma ext | June 10, 2026 |
| Z-2732-2026 | Class II | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma exte | June 10, 2026 |
| Z-2730-2026 | Class II | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation devi | June 10, 2026 |
| Z-2731-2026 | Class II | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma exter | June 10, 2026 |
| 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-0894-2026 | Class III | Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Numb | November 3, 2025 |
| 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-0891-2026 | Class III | Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/ | 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-0895-2026 | Class III | Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38 | 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 |