Rappel de Device Recall NexGen CR Complete Knee Solution

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Zimmer Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Zimmer has received 5 complaints where a nexgen cr micro articular surface was used with a standard cr femur, even though the compatibility chart and product labeling indicates that these components are not compatible. investigation identified additional instances where a cr micro articular surface and standard cr femur were sold together on the same purchase order. cr micro articular surfaces are.
  • Action
    Zimmer sent an Urgent Correction Notice dated March 5, 2012, to all affected customers via telephone, E-mail and letter notifying users of the appropriate compatibility of micro sizes of NexGen¿ CR and CR-Flex Articular Surfaces and informing them of known cases of incompatible devices being implanted, including associated risks. Customers and surgeons were asked to acknowledge receipt by calling 1-888-912-7349. Questions and concerns or help in notiying accounts about this correction were to be addressed to 1-888-548-8514. For questions regarding this recall call 574-372-4807.


  • Modèle / numéro de série
    Part 00-5972-020-20, 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
    00-5972-020-20, NexGen CR Complete Knee Solution, Cruciate Retaining (CR) Articular Surface Regular Constraint, Size Purple, AE Micro 20mm Height , Sterile R, Rx ,Zimmer, Inc. Warsaw, IN || 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


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