FDAApril 27, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

orthofix

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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