Recall Z-1977-2025 ยท HSB Rod, Fixation, Intramedullary And Accessories
Orthofix Srl
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
| Date | Jun 13, 2025 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Use error |
| Action | No official notification was sent to customers. Orthofix representative was present during the first clinical case and both devices were returned as part of the complaint investigation process. |
| Quantity | 2 units |
| Distribution | US: Unknown, OUS: Unknown |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233867 | Fitbone Trochanteric Orthofix Srl, Jun 18, 2024 |