Orthofix product recalled over fire hazard

Recall date

April 27, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Orthofix, Inc recalls Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx On…

Recall number

Z-1881-2016

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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