FDA Medical Device Recalls (openFDA)
Orthofix Srl: REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
- Recall number
- Z-1977-2025
- Recalling firm
- Orthofix Srl
- Product
- REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
- Status
- Open, Classified
- Initiated
- 2024-09-24
- Posted
- 2025-06-13
- Terminated
- not on file
- Reason
- Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
- Root cause
- Use error
- Action
- 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.
- Quantity
- 2 units
- Distribution
- US: Unknown, OUS: Unknown
- Lot, serial or model codes
- Lot # B4771336 and B4771337, UDI: 18059015373653
- 510(k) numbers
- ["K233867"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3002807827
- Firm city
- Bussolengo
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28