Events

Rappel de Device Recall Certain LowProfile, Angled 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, 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
    61473
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1456-2012
  • Date de mise en oeuvre de l'événement
    2012-01-10
  • Date de publication de l'événement
    2012-04-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108182
  • 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
    Biomet 3i initiated a recall for a small percentage of the 33mm (ilpac3217) abutment packages that may contain the 5mm (ilpac5217) abutment.
  • Action
    Biomet 3i , LLC sent Urgent: Medical Device Recall notices on 1/10/2012 to each customer in via e-mail, facsimile, telephone or postal mail. The letters identified the affected product and the reason for the recall. Each customer was instructed to check their respective inventory for the affected product and return any unused product to Biomet 3i at the address provided. Biomet 3i will issue replacement product at no charge. Questions or concerns should be directed to 1-800-342-5454.

Device

Device Recall Certain LowProfile, Angled Abutment
  • Modèle / numéro de série
    Lot Numbers: 2011060659, 2011070773, 2011070988, 2011071332, 2011071575, 2011080241, 2011080697, and 2011091179.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- Canada, Chile, Columbia, France, Germany, Hong Kong, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, UK, US, and Vietnam.
  • Description du dispositif
    Certain Low-Profile, Angled Abutment, Model Number ILPAC3217. Product is labeled in part: "***Biomet 3i***4555 Riverside Drive , Palm Beach Gardens, FL 33410 USA***REF ILPAC3217***LOT 2011091179***Certain Low Profile 17 Abutment***3.4mm(D) X 2mm(H)***Abutment:; Pillar; Abutment; Abutment; Pilastro; Pillar***CE dose***Use by 2016-09***Sterile using Radiation***RX Only***Do not reuse***Consult accompanying documents***Do not re-sterilize***Do not use if package is damaged***ILPAC3217***2011091179***"P-LBLNY3P***Rev. D***". || Intended to provide a means to attach crown restorations or implant frameworks to implants.
  • 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