Z-1977-2025 Class II Ongoing
FDA device recall Z-1977-2025 was initiated by Orthofix Srl on September 24, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2025
- Initiation Date
- September 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
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 Pattern
US: Unknown, OUS: Unknown
Code Information
Lot # B4771336 and B4771337, UDI: 18059015373653