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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0139-2013

6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.

Publicado el 31 de octubre de 2012 · Inicio del retiro: 28 de septiembre de 2012

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

A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Encore Medical, Lp
Distribuidor
Nationwide Distribution only to CA.
Lote
Model Number 10-55-025, Lot Number 006A1057.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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