FDA Recall
Open, Classified
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Recall: Z-1977-2025
·
Initiated September 24, 2024
Recall
- Recall Number
- Z-1977-2025
- Event Number
- 96905
- Firm
- Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy
- FEI Number
- 3002807827
- Product Code
- HSB
- Status
- Open, Classified
- Root Cause
- Use error
- Initiated
- September 24, 2024
- Posted
- June 13, 2025
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.
Action
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.
Distribution
US: Unknown, OUS: Unknown
Quantity
2 units