Recall archive / FDA device enforcement
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile — FDA record Z-1977-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Orthofix Srl
- Quantity
- 2 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1977-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # B4771336 and B4771337, UDI: 18059015373653 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: Unknown, OUS: Unknown
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 25, 2025
- Recall initiation date
- Sep 24, 2024
- Center classification date
- Jun 13, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.