Events

Rappel de BioMend Absorbable Collagen Membrane/Wound DressingBioMend Absorbable Collagen Membrane; BioMend Extend Absorbable Collagen Membrane; CollaCote Absorbable Collagen Wound Dressing for Dental Surgery; CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery; CollaTape Absorbable Collagen Wound Dressing for Dental Surgery

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 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-2013-RN-00427-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-10
  • 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-2013-RN-00427-1
  • 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
    Due to a manufacturing process deviation these products may have been released with higher levels of endotoxins than permitted by the specifications for the products.
  • Action
    Zimmer Dental is requesting their customers to remove any affected units from service. Patients implanted with affected products should be monitored for fever in the immediate postoperative period according to the standard hospital protocol.

Device

BioMend Absorbable Collagen Membrane/Wound DressingBioMend Absorbable Collagen Membrane; BioMend ...
  • Modèle / numéro de série
    BioMend Absorbable Collagen Membrane/Wound DressingBioMend Absorbable Collagen Membrane; BioMend Extend Absorbable Collagen Membrane; CollaCote Absorbable Collagen Wound Dressing for Dental Surgery; CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery; CollaTape Absorbable Collagen Wound Dressing for Dental SurgeryMultiple lot and catalogue numbers affectedARTG Number: 159199
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer 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