Events

Rappel de Device Recall InnerVue Diagnostic Scope System

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
    57965
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1589-2011
  • Date de mise en oeuvre de l'événement
    2011-02-10
  • Date de publication de l'événement
    2011-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97864
  • 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
    laparoscope - Product Code HRX
  • Cause
    The cannula could not be connected to the scope and scopes disengage during use. the outer hub of innervue scopes may become detached from the inner hub of the scopes during assembly of the scope to the innervue hand piece. this condition may prevent the innervue scope from being securely attached to the innervue hand piece.
  • Action
    On 2/10/2011, Biomet issued an "URGENT MEDICAL DEVICE NOTICE" to their Direct Accounts instructing customers to identify and discontinue use of the recalled products and return them to Biomet. Response forms were provided.

Device

Device Recall InnerVue Diagnostic Scope System
  • Modèle / numéro de série
    PART NUMBER 922141, LOT NUMBERS-649680, 818630, 390060, 968890, 783990, 784000
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution USA nationwide and to the Netherlands
  • Description du dispositif
    Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERILE
  • 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