FDAFDA · Food and drugs·Recall number Z-1977-2025
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Published June 25, 2025 · Recall initiated: September 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Orthofix Srl
- Distributor
- US: Unknown, OUS: Unknown
- Lot
- Lot # B4771336 and B4771337, UDI: 18059015373653
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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