Fitbone Trochanteric Nail (Orthofix) – Potential Bending (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Brand
Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy
Lot Codes / Batch Numbers
Lot # B4771336 and B4771337, UDI: 18059015373653
Products Sold
Lot # B4771336 and B4771337, UDI: 18059015373653
Orthofix Srl Via Delle Nazioni 9 Bussolengo Italy is recalling REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile due to Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in hav. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026