FDA-Device2017-09-20Class II
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
Orthofix, Inc
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.
Sold states
Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Affected count
6 planers
Manufactured in
3451 Plano Pkwy, N/A, Lewisville, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3127-2017Don't want to check this manually?
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