Events

Rappel de Biomet Series A Standard Patella size 25mm, three pegs 184760

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 Biomet, 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
    60144
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0700-2012
  • Date de mise en oeuvre de l'événement
    2011-10-04
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105830
  • 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
    Prothesis, knee,patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Cause
    Correcting language on product labeling which incorrectly states patella buttons are intended for use with the agc knee system.
  • Action
    Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.

Device

Biomet Series A Standard Patella size 25mm, three pegs 184760
  • Modèle / numéro de série
    Part 184760, Lot 190410, 369920, 423430, 572150, 633870, 721650.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.
  • Description du dispositif
    Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582 || For use with Vanguard, Maxim, Ascent & AGC Knee Systems || Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. || Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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