Events

Rappel de Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Zimmer Biomet Pty 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
    RC-2017-RN-00819-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00819-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The design verification for the previous packaging configuration does not cover the 70cm wires. whilst there has not been any complaints involving a breach in sterility, zimmer has completed a design verification to move the 70cm guide wires to a new packaging configuration. as a result, the products packaged in the previous packaging configuration are being retrieved from the market.
  • Action
    Zimmer is requesting that Customers: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Assist your Zimmer Biomet sales representative by quarantining all affected product; 3. A Zimmer Biomet sales representative will remove the affected product from your facility; 4. Complete the Certificate of Acknowledgement as supplied by Zimmer; 4.a Return a digital copy to RAQA.ANZ@zimmerbiomet.com; and 4.b Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.

Device

Trauma Guide Wires, 70cm Ball Tip Guide Wire 2.4mm, Tear Drop Guide Wire
  • Modèle / numéro de série
    Trauma Guide Wires, 70cmBall Tip Guide Wire 2.4mmItem Number: 47-2255-008-003mm x 70cm Tear Drop Guide WireItem Number: 47-2490-098-00Expiry Date: April 2022ARTG Number: 118540
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet Pty Ltd
  • 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
    DHTGA