Events

Rappel de Device Recall Stright Ringloc Button Latch Inserter Handle

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
    64354
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0925-2013
  • Date de mise en oeuvre de l'événement
    2013-02-05
  • Date de publication de l'événement
    2013-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115921
  • 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 straight ringloc button latch inserter handle may have been manufactured at the higher end of the tolerance causing interference with the ringloc cup. the inserter handle may lock onto the cup during impaction. if alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
  • Action
    BIOMET sent an Urgent Recall Notice beginning February 13, 2013, to all affected customers. The notice included possible adverse events and directions to locate and remove identified devices by returning a Fax Back Response Form to 574-372-1683 and obtaining an RGA # prior to return of product to Biomet, Inc. 56 East Bell Drive Warsaw, IN 46580. Questions should be directed to 574 372-1570 M-F, 8 a.m.-5.p.m. For questions regarding this recall call 574-267-6639, ext 1676.

Device

Device Recall Stright Ringloc Button Latch Inserter Handle
  • Modèle / numéro de série
    Catalog Number 5313152 Lot 153880,153930, 415500, 648010
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
  • Description du dispositif
    REF S313152 Straight Acetabular Inserter Handle Ringloc || non-sterile || Orthopedic manual surgical instrument
  • 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