FDAFDA · Food and drugs·Recall number Z-3127-2017
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication
Published September 20, 2017 · Recall initiated: August 2, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthofix, Inc
- Distributor
- Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
- Lot
- Lot #203013-TD26
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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