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Terminated

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

FDA Recall Z-1881-2016 · Posted 2016-06-01

Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeHXX
Date Initiated2016-04-27
Date Terminated2016-11-23
Product Quantity36 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016-01-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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