Events

Rappel de Device Recall BIOMET 3i

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, LLC.

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
    68915
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2594-2014
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • Date de publication de l'événement
    2014-09-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129004
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • Cause
    Identifiers on the label are correct but the label has the incorrect color coding.
  • Action
    Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.

Device

Device Recall BIOMET 3i
  • Modèle / numéro de série
    Model Number IEHA458, Lot number: 1167545.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution to NH and TX.
  • Description du dispositif
    BIOMET 3i Certain Bellatek Encode Healing Abutment || Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
  • Manufacturer
    Biomet 3i, LLC

Manufacturer

Biomet 3i, LLC
  • Adresse du fabricant
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • 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