Firebird NXG Spinal Fixation System Decorticating Planer recalled over fire hazard

Recall date

August 2, 2017

Source

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

Official notice title

Orthofix, Inc recalls Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is…

Recall number

Z-3127-2017

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.

Why it was recalled

The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.

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

What was recalled

Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication