Events

Rappel de Offset reamer brushing angled

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
    57273
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0829-2011
  • Date de mise en oeuvre de l'événement
    2010-09-10
  • Date de publication de l'événement
    2010-12-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95806
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Cause
    The firm has initiated the action following a report that during surgery the offset reamer brushign would not mate with the prepartion mask. after a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. there was no injury to the patient.
  • Action
    The firm, BIOMET, sent a "FIELD SAFETY NOTICES" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached "FAX BACK RESPONSE FORM" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, Bridgend, CF31 3XA. The customers were also instructed to inform all in their organization who are using or ordering the products and send a copy to the organization to which potentially affected products may have been transferred. If you have any questions regarding this communication, please contact the Quality Manager at +44 (0) 1656 655221 or email: david.broderick@biomet.com.

Device

Offset reamer brushing angled
  • Modèle / numéro de série
    1723336, 1768306, 2049011, ZB090424.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark
  • Description du dispositif
    Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. || This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
  • 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