Device product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Z-1977-2025
Product summary
- Firm
- Orthofix Srl
- Event
- Event 96905
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1977-2025
Official wording
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 information: Lot # B4771336 and B4771337, UDI: 18059015373653
Distribution pattern: US: Unknown, OUS: Unknown
Derived failure modes
-
Unknown
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.