Recall Z-3127-2017— Orthofix, Inc

Name: FDA recall Z-3127-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-02

Class II · Terminated

Class II FDA medical device recall by Orthofix, Inc, initiated 2017-08-02, terminated 2018-05-04. It names one FDA 510(k) clearance: K171082. 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: 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..

Recalling firm: Orthofix, Inc
Classification: Class II
Status: Terminated
Initiated: 2017-08-02
Terminated: 2018-05-04
Firm location: Lewisville, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K171082 — Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation SystemOrthofix, Inc.·cleared 2017-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.