Events

Rappel de Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks

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
    50698
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0878-2009
  • Date de mise en oeuvre de l'événement
    2008-12-18
  • Date de publication de l'événement
    2009-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76185
  • 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
    Manual Surgical Instrument for General Use - Product Code HTZ
  • Cause
    Falling component: the universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
  • Action
    Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.

Device

Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks
  • Modèle / numéro de série
    Lots 084280 and 132702.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • Description du dispositif
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
    Biomet, Inc.

Manufacturer

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