Class II — Orthofix U.S. LLC
| Recalling firm | ORTHOFIX SRL |
|---|---|
| Registered facility | ORTHOFIX SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm. |
| Product | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees. |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of California, Colorado, and Missouri. |
| Initiated | 2025-02-20 |
| Classified | 2025-03-21 |
| Recall number | Z-1432-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Orthofix U.S. LLC (Z-1432-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96351/
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