FDA recall Z-3127-2017

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

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-08-02

Report date

2017-09-20

Termination date

2018-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lewisville, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3127-2017