FDAFDA · Alimentos y medicamentos·N.º oficial Z-1867-2017
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
Publicado el 26 de abril de 2017 · Inicio del retiro: 28 de marzo 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
Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying carbon fiber structure of the Wilson frame and could lead to a pressure injury.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Mizuho OSI
- Distribuidor
- United States, Canada, Japan, Australia, New Zealand, Great Britain, Sweden, Spain, Germany, Switzerland, Kenya, Saudi Arabia, Hong Kong, South Korea.
- Lote
- All Lots: Manufacturing dates: December 2016 through March 2017; GTIN:00842430100192
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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