Device Recall NexGen CompleteKnee Solution, Prolong

  • Modèle / numéro de série
    Part 00595202010, all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
  • Description du dispositif
    00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Part 00595202012, all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
  • Description du dispositif
    00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complet Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
  • Manufacturer
  • Modèle / numéro de série
    Part 00595202017, all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
  • Description du dispositif
    00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
  • Manufacturer
  • Modèle / numéro de série
    Part 00-5970-02023, all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
  • Description du dispositif
    00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
  • Manufacturer
  • Modèle / numéro de série
    Part 90595202012, all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Poland, Taiwan, Denmark, Korea, Singapore, China, Canada, Australia, Japan, France, Italy, UK, Germany, Spain, Belgium, Portugal, Switzerland, Sweden, India, Thailand, Peru, The Netherlands, Malaysia, and Austria.
  • Description du dispositif
    90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN || The NexGen Articular Surface serves as a spacer between the baseplate of the Intended Use. tibia and the metal implant that covers the end of the femur. The micro articular surfaces are made of either conventional or prolong polyethylene in thicknesses of 9. 10, 12, 14, 17, or 20mm. The articulating surface of the device is conforming to the geometry of the NexGen micro femoral components. The articular surface locks into the tibial baseplate and is contained by a peripheral rail. The articular surface is explantable without removing the tibial base plate. The NexGen Complete Knee System ,integrated, with an extensive cruciate retaining, cruciate substituting, and fully constrained component configurations, design specific, conforming surfaces, femoral and tibial augmentation. The femoral, patellar, articular surface, and tibial base plate components should be design specific to the condition and availability of the bone stock, and the condition and functionality of soft tissues. This allows the surgeon to select the most appropriate component combination to meet specific patient needs. Articulating surfaces on micro femoral and tibial components have a smaller bearing spacing than those on the standard and macro components.
  • Manufacturer