Z-1977-2025Class II

REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile

Name: Z-1977-2025 REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Creator: Orthofix Srl
Published: 2024-09-24
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2024-09-24 / Open, Classified

FDA source

Orthofix Srl began a recall of REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile on 2024-09-24. FDA classified it as Class II and gives the reason as "Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1977-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-24
Posted: 2025-06-13
Recalling firm: Orthofix SRL
Product: REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
FDA 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 in commerce: 2 units
Distribution: US: Unknown, OUS: Unknown
Product codes and lots: Lot # B4771336 and B4771337, UDI: 18059015373653

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1977-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1977-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-13

Product code HSB

K233867Class IIFitbone TrochantericOrthofix Srl / cleared 2024-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)