Events

Rappel de Device Recall Certain MicroMiniplant Straight Healing Abutment

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 3i, 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
    47341
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1365-2008
  • Date de mise en oeuvre de l'événement
    2008-02-06
  • Date de publication de l'événement
    2008-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-07-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69247
  • 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
    Healing Abutment - Product Code NHA
  • Cause
    Seating problems: the micro-miniplant straight healing abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.
  • Action
    USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.

Device

Device Recall Certain MicroMiniplant Straight Healing Abutment
  • Modèle / numéro de série
    Lot Number: 593025-5
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide
  • Description du dispositif
    BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.
  • Manufacturer
    Biomet 3i, Inc.

Manufacturer

Biomet 3i, Inc.
  • Adresse du fabricant
    Biomet 3i, Inc., 4555 Riverside Drive, Palm Beach Gardens FL 33410
  • 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