REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
This recall is currently active, issued June 13, 2025. It was issued by Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy.
- Recall Initiated
- September 24, 2024
- Posted
- June 13, 2025
- Recall Number
- Z-1977-2025
- Quantity
- 2 units
- Official Source
- View on FDA website ↗
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.
Distribution
US: Unknown, OUS: Unknown
Lot / Code Info
Lot # B4771336 and B4771337, UDI: 18059015373653
Root Cause
Use error
Action Taken
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.