FDAFDA · Alimentos y medicamentos·N.º oficial Z-2145-2012
Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous tissue resection and in hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringers lactate or other conductive solutions as an irrigant under direct or video assisted fiberoptic visualization.
Publicado el 15 de agosto de 2012 · Inicio del retiro: 14 de julio 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
Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months for which product and package reliability has not been validated.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smith & Nephew, Inc. Endoscopy Division
- Distribuidor
- Worldwide Distribution - US Nationwide and the countries of : Australia, Canada, Korea, Turkey, UAE, and Japan.
- Lote
- Lot Numbers: 655844R, 950143R, 950144R, 950145R, 950146R
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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