REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm… recallZ-1977-2025 · Orthofix Srl · initiated Sep 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix Srl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Use error
What the company is doing
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.
Recall details
- Recall number
- Z-1977-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 24, 2024
- Posted by the FDA
- Jun 13, 2025
- Recalling firm
- Orthofix Srl
- Quantity
- 2 units
- Product code
- HSB
- FDA submissions
- K233867
- Distribution
- US: Unknown, OUS: Unknown
Product description
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Code information (models, lots, serial numbers)
Lot # B4771336 and B4771337, UDI: 18059015373653
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ORTHOFIX 1Orthofix Srl · Rod, Fixation, Intramedullary And Accessories1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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