Z-1881-2016Class II

Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation...

Name: Z-1881-2016 Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation...
Creator: Orthofix, Inc
Published: 2016-04-27
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2016-04-27 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile on 2016-04-27. FDA classified it as Class II and gives the reason as "There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1881-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-27
Posted: 2016-06-01
Terminated: 2016-11-23
Recalling firm: Orthofix SRL
Product: Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Product code: HXX Screwdriver
Reason for recall: There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Root cause tag: design
FDA root cause: Device Design
Action: Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.
Quantity in commerce: 36 units
Distribution: KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1881-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1881-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-01

Product code HXX

K153428Class IIFirebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. / cleared 2016-01-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)