Events

Rappel de Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Biomet Australia 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-2016-RN-00206-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-02-24
  • 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-2016-RN-00206-1
  • 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
    An investigation has identified that verso shoulder forked retractor part number 402582 was manufactured using 420 stainless instead of 420 s29 stainless steel. 420 stainless steel is more brittle than 420 s29. the instrument may fracture during use. if the retractor fractures during surgery, surgical intervention may be necessary to retrieve any fractured pieces. a delay in surgery greater than 30 minutes may occur. if the pieces are unable to be retrieved, the patient would retain a foreign body.
  • Action
    The sponsor is advising users to inspect stocks and quarantine the affected units. The sponsor will remove and replace the affected units. This action has been closed-out on 25/01/2017.

Device

Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))
  • Modèle / numéro de série
    Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))Part number: 402852All Lots affectedARTG Number: 177811
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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