FDA Device recall Z-1977-2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile by Orthofix Srl, citing retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1977-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-24 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Orthofix Srl |
| Distribution | n/a |
Product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
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.
Identifiers
| code_info | Lot # B4771336 and B4771337, UDI: 18059015373653 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.