Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Firebird NXG Spinal Fixation System Set Screw Driver used to Recalled by Orthofix, Inc Due to There is a possibility that the subject set...

Date: April 27, 2016
Company: Orthofix, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Orthofix, Inc directly.

Affected Products

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

Quantity: 36 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 14 states: AZ, CA, FL, ID, KS, MA, MI, NV, NH, NJ, SC, TX, UT, WA

Affected (14 states)Not affected

About Orthofix, Inc

Orthofix, Inc has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report