Events

Rappel de Device Recall NexGen 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
    Recall
  • ID de l'événement
    65413
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2003-2013
  • Date de mise en oeuvre de l'événement
    2013-06-07
  • Date de publication de l'événement
    2013-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118819
  • 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
    Surgeons are implanting components of the nexgen cruciate retaining (cr) complete knee system in combinations that are not approved (micro with standard). includes cr micro femurs, articular surface, patellae, instruments and provisionals combined with standard components. a march 2012 recall reiterated the proper combination labeling, but the mis match problem continues. zimmer is removing the d.
  • Action
    Beginning June 7, 2013 all distributors will be sent Urgent Device Recall notices via electronic mail, with distributors, hospital risk managers with affected inventory also receiving the notice via courier. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product is to be returned to Zimmer Product Service Department , 1777 West Center St. Warsaw, IN 46580 or internation return at Zimmer International Logistics GmbH, Max - Immelmann Allee 12 79427 Eschbach Germany. " Communications outside of the United States will occur approximately two weeks after the United States communications.

Device

Device Recall NexGen Complete Knee Solution
  • Modèle / numéro de série
    all codes
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Japan.
  • Description du dispositif
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; || 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; || 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; || 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx, Sterile; || 00597104120 Provisional CR ART SURF PROV 56/STR GRN 20, Rx, Sterile; || 00597104123 Provisional CR ART SURF PROV 56/STR GRN 23, Rx, Sterile; || Used in total knee arthroplasty and indicated for patients with severe pain.
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Adresse du fabricant
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA