Events

Rappel de Device Recall Oxford Gap Gauge

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
    62745
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2224-2012
  • Date de mise en oeuvre de l'événement
    2012-07-27
  • Date de publication de l'événement
    2012-08-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111582
  • 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
    Device, prosthesis alignment - Product Code IQO
  • Cause
    A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. the cad model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension.
  • Action
    Biomet sent a "FIELD SAFETY CORRECTIVE ACTION" letter dated July 24, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Response Form was attached for customers to complete and return. Contact the firm for questions regarding this notice.

Device

Device Recall Oxford Gap Gauge
  • Modèle / numéro de série
    Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA-including the states of IN, SD, and TX and the countries of Austria, China, Japan, Netherlands, Sweden, Turkey, and UK.
  • Description du dispositif
    Oxford Gap Gauge SML 3/4mm. || The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.
  • 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