REF: 99-709245 — Class II medical device recall Z-1977-2025
Ongoing recall by Orthofix Srl, reported 2025-06-25. Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal
| Recall number | Z-1977-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix Srl, Bussolengo, N/A, Italy |
| Recall initiated | 2024-09-24 |
| Classified | 2025-06-13 |
| Reported by FDA | 2025-06-25 |
| Quantity | 2 units |
| UPC / GTIN / UDI-DI | 18059015373653 |
| Lot numbers | B4771336, B4771337 |
| Model numbers | 99-709245 |
Product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Reason for recall
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1977-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.