Events

Rappel de Device Recall Mallory Head 4 Finned Acetabular Shell 50mm

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
    70438
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1122-2015
  • Date de mise en oeuvre de l'événement
    2015-01-09
  • Date de publication de l'événement
    2015-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133700
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Cause
    Biomet recalled the mallory head 4 finned acetabular shell 50mm (lot 364600) and ringloc + acetabular shell limited hole finned 52 mm (lot 427840) following a mix up in packaging with the two.
  • Action
    Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., audrev.daenzer@biomet.com, or 574-372-1570 Monday- Friday 8 AM to 5 PM.

Device

Device Recall Mallory Head 4 Finned Acetabular Shell 50mm
  • Modèle / numéro de série
    Catalog Number: 13-104150 Lot Number Identification: 364600
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of VA and TX and the country of Japan.
  • Description du dispositif
    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
  • Manufacturer
    Biomet, Inc.

Manufacturer

Biomet, Inc.
  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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