Class II — Orthofix Srl
| Recalling firm | ORTHOFIX SRL |
|---|---|
| Registered facility | ORTHOFIX SRL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced. |
| Product | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile |
| Quantity | 2 units |
| Distribution | US: Unknown, OUS: Unknown |
| Initiated | 2024-09-24 |
| Classified | 2025-06-13 |
| Recall number | Z-1977-2025 |
| 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 Srl (Z-1977-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96905/
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