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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1108-2016

Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF 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:61854116 61930079
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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