PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 25, 2025 Initiated: September 24, 2024 #Z-1977-2025

Product Description

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

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.

Details

Recalling Firm
Orthofix Srl
Units Affected
2 units
Distribution
US: Unknown, OUS: Unknown
Location
Bussolengo, N/A

Frequently Asked Questions

What product was recalled?
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile. Recalled by Orthofix Srl. Units affected: 2 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1977-2025.