Events

Rappel de Device Recall Vanguard Distal Cut Block

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 U.K., Ltd..

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
    61274
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1222-2012
  • Date de mise en oeuvre de l'événement
    2012-02-14
  • Date de publication de l'événement
    2012-03-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107699
  • 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
    This recall was initiated following a report that a bag labeled as ref. 32-487557/lot no 2561334 (vanguard tibial resection head universal w/ alignment tower) actually contained a ref. 32-487002/lot no. 2561329 (vanguard distal cutting block w/out handle attachment). investigation found packaging of the affected product may contain the incorrect item.
  • Action
    Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com

Device

Device Recall Vanguard Distal Cut Block
  • Modèle / numéro de série
    REF 32-487002, Lot 2561329
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
  • Description du dispositif
    Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK || Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
  • Manufacturer
    Biomet U.K., Ltd.

Manufacturer

Biomet U.K., Ltd.
  • Adresse du fabricant
    Biomet U.K., Ltd., Waterton Industrial Estate, Bridgend, South Wales United Kingdom
  • 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