FDA Medical devices recall ·
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recall
- Recall number
- Z-1977-2025
- Date
- (initiated September 24, 2024)
- Company / brand
- Orthofix Srl
Via Delle Nazioni 9, Bussolengo, N/A, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Why was it recalled?
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # B4771336 and B4771337, UDI: 18059015373653
Distribution
US: Unknown, OUS: Unknown
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1977-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.