Events

Rappel de iASSIST Validation Tool

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-00397-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-31
  • 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-00397-1
  • 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 manufacturer has received an increased number of complaints regarding bent or broken drive pins of the iassist validation tool manufactured with drawing revision m to p. breakage of the drive pin or drive pin head will lead to the parts having to be retrieved and hence, a delay in treatment.Only iassist validation tools with drawing revision m to p drive pins are affected (they have a x cross section instead of circular and the drive pin head has a recess in the enlarged head).
  • Action
    Zimmer Biomet is advising surgeons that the affected products can continue to be used until replacements are available. In the interim, the Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2) and specifically the warning on pages 36 and 37 regarding applying excessive force, should be followed in order to minimize the chances of bending or breakage during use. In addition, surgeons should inspect affected devices before and immediately after use to confirm that the drive pins are not bent or broken. In the event of breakage, the drive pin head will disassemble and therefore surgeons should ensure that both parts are retrieved from the wound.

Device

iASSIST Validation Tool
  • Modèle / numéro de série
    iASSIST Validation ToolModel Number: 20-8011-021-00 Rev M-PARTG Number: 205936
  • 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