Events

Rappel de Biomet Microfixation TraumaOne System Surgical Tray

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 Microfixation, 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
    77022
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2073-2017
  • Date de mise en oeuvre de l'événement
    2017-04-11
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154834
  • 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
    Template - Product Code HWT
  • Cause
    Part of the number on the tray lid differ from the part number on the base.
  • Action
    On April 11, 2017 the firm sent notifications to all affected US and International distributors, which will include instructions for returning affected products. All distributors will be notified via electronic mail, and US distributors with product, will be notified via courier. o Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals which currently have the product. o Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the additional accounts form provided in the letter. o Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. For more information contact corporatequality.postmarket@zimmerbiomet.com or 904-367-7133 (8:am - 5pm EST)

Device

Biomet Microfixation TraumaOne System Surgical Tray
  • Modèle / numéro de série
    Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AL, MO and UT Canada, Australia, Netherlands, and Egypt
  • Description du dispositif
    Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
  • Manufacturer
    Biomet Microfixation, LLC

Manufacturer

Biomet Microfixation, LLC
  • Adresse du fabricant
    Biomet Microfixation, LLC, 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 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