Orthofix Srl: Device Recall
Recall #Z-1977-2025 · 09/24/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1977-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Orthofix Srl
- Status
- Ongoing
- Date Initiated
- 09/24/2024
- Location
- Bussolengo, N/A, Italy
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Product Description
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Distribution Pattern
US: Unknown, OUS: Unknown
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.