ORTHOFIX Firebird Spinal Fixation System 6 recalled over fire hazard

Recall date

May 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Orthofix, Inc recalls ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only…

Recall number

Z-1749-2015

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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