FDAFDA · Alimentos y medicamentos·N.º oficial 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
Publicado el 20 de septiembre de 2017 · Inicio del retiro: 2 de agosto de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Orthofix, Inc
- Distribuidor
- Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
- Lote
- Lot #203013-TD26
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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