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

Recalled September 20, 2017 · FDA recall Z-3127-2017 · Orthofix

Hazard

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. · FDA Class II

Units

6 planers

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Orthofix, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →