Events

Rappel de DAL-RO ABUTMENT SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS 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
    23265
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-11-30
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    During the investigation of a customer complaint two packages of locator abutments (loa002) were confirmed to have not been sealed during manufacturing.

Device

DAL-RO ABUTMENT SET
  • Modèle / numéro de série
    Model Catalog: DRH40 (Lot serial: >10 CONTACT MFR); Model Catalog: DRH20 (Lot serial: >10 CONTACT MFR); Model Catalog: THRC4 (Lot serial: >10 CONTACT MFR); Model Catalog: IOLHC (Lot serial: >10 CONTACT MFR); Model Catalog: CA002 (Lot serial: >10 CONTACT MFR); Model Catalog: >10 CONTACT MFR (Lot serial: >10 CONTACT MFR); Model Catalog: MHC33 (Lot serial: >10 CONTACT MFR); Model Catalog: LORHK (Lot serial: >10 CONTACT MFR); Model Catalog: LOAH (Lot serial: >10 CONTACT MFR); Model Catalog: OSO60 (Lot serial: >10 CONTACT MFR); Model Catalog: OSO40 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA53 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA52 (Lot serial: >10 CONTACT MFR); Model Catalog: WCA51 (Lot serial: >10 CONTACT MFR); Model Catalog: DRTH (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA006 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA005 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA004 (Lot serial: >10 CONTACT MFR); Model Catalog: ILOA003 (Lot serial: >10 CONTACT MFR); Model Catalog: ICA0
  • Description du dispositif
    DAL-RO ABUTMENT SET
  • Manufacturer
    BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS INC.

Manufacturer

BIOMET 3I ALSO TRADING AS IMPLANT INNOVATIONS INC.
  • Adresse du fabricant
    PALM BEACH GARDENS
  • 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
    HC