Events

Rappel de Device Recall Incise Zirconia Coping (CBZR0102)

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
    58769
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2838-2011
  • Date de mise en oeuvre de l'événement
    2010-12-01
  • Date de publication de l'événement
    2011-07-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100493
  • 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
    Restoration, porcelain - Product Code NSP
  • Cause
    On december 1, 2010 biomet 3i recalled their product incise zirconia coping (cbzr0102). the coping contains a manufacturing defect. coping is oversized. all affected direct accounts were notified by letter on december 14, 2010.
  • Action
    Biomet 3i sent an "MEDICAL DEVICE RECALL" letter dated December 14, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken. The letter instructs customers to complete and fax the Product Recall Response form to 561-514-6316. In addition, a shipping label is enclosed with the letter for returning the affected product. Customers with questions and concerns should contact Biomet 3i recall coordinator at 561-776-6906.

Device

Device Recall Incise Zirconia Coping (CBZR0102)
  • Modèle / numéro de série
    Lot numbers: 97646, 97415, 97418, 97422, 97417 97421, 97420, 97481, 97423, 97419, 97488, 97476, 97478, 97486 97490, 97416.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the country of Canada.
  • Description du dispositif
    "***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework***Biomet 3i 4555 Riverside Drive Palm Beach Gardens, FL 33410 800-342-5454 www.biomet3i.com Please consult instructions for use and recommendation***For Dental Lab use ONLY Non-sterile/For single Use***" || Indicated for use in restorative procedure to affix the final prosthesis to the abutment. Coping and frameworks provide the base structure for final porcelain application as the final step of creating a restoration. The devices are intended to be used to create final restoration for dental reconstruction with either a prepared tooth or dental implant abutment.
  • 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