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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