Events

Rappel de Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve

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, Inc..

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
    49709
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0288-2009
  • Date de publication de l'événement
    2008-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74060
  • 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
    Fixation Cerclage - Product Code JDQ
  • Cause
    The outer package is properly labeled, but the inner package may be labeled as a femoral component.
  • Action
    The firm's sales force was notified of the problem via an Urgent Medical Device Removal Notice letter dated 9/24/08, and provided instructions to retrieve the product from customer accounts and to provide them with a copy of the removal letter. Distributors were to immediately locate and remove the identified implants from circulation, carefully follow the instructions, and fax a copy of the Response Form prior to the return of the product. If the product was further distributed, hospital personnel MUST be notified via the enclosed "Dear Biomet Customer" notice. The letter MUST be given to hospital personnel responsible for receiving recall notices but distributors are charged with the location and return of those products.

Device

Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve
  • Modèle / numéro de série
    Lot 568400.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution --- USA including states of Arkansas, Florida, Kansas, New Jersey, and Ohio, and countries of Argentina, Canada, Chile Italy, Mexico and United Kingdom.
  • Description du dispositif
    Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805. || Intended for general orthopedic repairs including long bone fractures, bone grafting, reinforcement of bone and reattachment of the greater trochanter.
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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