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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1103-2016

Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM, S 47482701601 2.7MM CORT. SCREW 16MM, S 47482701801 2.7MM CORT. SCREW 18MM, S 47482702001 2.7MM CORT. SCREW 20MM, S Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Publicado el 23 de marzo de 2016 · Inicio del retiro: 11 de enero de 2016

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

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Zimmer Manufacturing B.V.
Distribuidor
US Nationwide Distribution
Lote
lot no: 61920802 62254418 61920804 61920805 61920806 62040737 61920807 62040736 61929794 62040738
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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