Z-3127-2017Class II

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

Name: Z-3127-2017 Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating...
Creator: Orthofix, Inc
Published: 2017-08-02
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2017-08-02 / Terminated / root cause: manufacturing process

FDA source

Orthofix, Inc began a recall of Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding... on 2017-08-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3127-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-02
Posted: 2017-08-18
Terminated: 2018-05-04
Recalling firm: Orthofix SRL
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.
Quantity in commerce: 6 planers
Distribution: Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Product codes and lots: Lot #203013-TD26

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3127-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3127-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-12

Product code NKB

K171082Class IIFirebird 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

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)