Orthofix, Inc: Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.

Recall number

Z-1881-2016

Recalling firm

Orthofix, Inc

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.

Status

Terminated

Initiated

2016-04-27

Posted

2016-06-01

Terminated

2016-11-23

Reason

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

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

36 units

Distribution

KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA

Lot, serial or model codes

All lots

510(k) numbers

["K153428"]

PMA numbers

not on file

Product code

HXX

Firm FEI

2183449

Firm city

Lewisville

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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