Orthofix, Inc: Medical Device Recall in 2015 - (Recall #: Z-1749-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

Product Classification:

Class II

Date Initiated: May 18, 2015

Date Posted: June 17, 2015

Recall Number: Z-1749-2015

Event ID: 71297

Reason for Recall:

The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

Status: Terminated

Product Quantity: 45 units

Code Information:

Lot Number S29

Distribution Pattern:

US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.

Voluntary or Mandated:

Voluntary: Firm initiated