REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
FDA device recall Z-1977-2025 · posted 2025-06-13 · Open, Classified
Recall details
- Recalling firm
- Orthofix Srl
- 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.
- Action taken
- 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.
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- HSB
- Quantity affected
- 2 units
- Distribution
- US: Unknown, OUS: Unknown
- Date initiated
- 2024-09-24
- Date posted
- 2025-06-13
- Location
- Bussolengo, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Fitbone Trochanteric (K233867) | Orthofix Srl | 2024-06-18 |