FDAFDA · Alimentos y medicamentos·N.º oficial Z-1295-2014
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, 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 Ushaped; 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 2 de abril de 2014 · Inicio del retiro: 11 de marzo de 2014
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
The products are being recalled because they did not meet minimum needle attachment strength requirements.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Teleflex Medical
- Distribuidor
- Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
- Lote
- Product Code: X-4981M4, Lot number: 02J0800451
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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