Device Recall Nextgen Complete Knee System

  • Modèle / numéro de série
    Part 00-5970-031-20, all lots
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • 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
    REF 00-5970-031-20, Nextgen Complete Knee System, Prolong highly crosslinked polyethylene Cruciate Retaining (CR) Micro Articular Surface Size Striped Yellow 20 mm Height , Sterile R, 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


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