Events

Rappel de Gold Slotted Screw

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
    54371
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1956-2010
  • Date de mise en oeuvre de l'événement
    2009-10-06
  • Date de publication de l'événement
    2010-07-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92313
  • 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
    implant, endosseous, root-form - Product Code DZL
  • Cause
    Biomet 3i, palm beach gardens, fl is recalling their gold slotted retaining screw 3mm, model number gs300. product is out of specification - product was manufactured with a material not specified for use in this product.
  • Action
    Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a faxed letter. International customers were first notified by e-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product 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. Questions or concerns are directed to Kelly Taylor at the firm at 561-776-6700.

Device

Gold Slotted Screw
  • Modèle / numéro de série
    Lots 868517, 865348, and 868515.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.
  • Description du dispositif
    BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. || BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.
  • 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