Orthofix Srl: Medical Device Recall in 2025 - (Recall #: Z-1977-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 24, 2024

Date Posted: June 25, 2025

Recall Number: Z-1977-2025

Event ID: 96905

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

Lot # B4771336 and B4771337, UDI: 18059015373653

Distribution Pattern:

US: Unknown, OUS: Unknown

Voluntary or Mandated:

Voluntary: Firm initiated