FDA Enforcement
Class II
Ongoing
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Recall: Z-1977-2025
·
Reported June 25, 2025
Enforcement
- Recall Number
- Z-1977-2025
- Event ID
- 96905
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthofix Srl
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- June 25, 2025
- Initiation Date
- September 24, 2024
- Classification Date
- June 13, 2025
- Address
- Via Delle Nazioni 9, N/A, Bussolengo, N/A, N/A, Italy
Description
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.
Code Info
Lot # B4771336 and B4771337, UDI: 18059015373653
Distribution
US: Unknown, OUS: Unknown
Quantity
2 units