Events

Rappel de Provide Protection Caps and Provide Impression Copings

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 3i 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-2015-RN-01113-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-16
  • 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-2015-RN-01113-1
  • 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
    It has been determined that the provide protection caps (ppc***) and the provide impression copings (pic***) elicit a cytotoxic response (grade 4). the affected products are intended for single, short-term use. the affected products were also distributed within certain provide abutment placement kits (pak****) as well as within certain provide abutment restorative kits (prk***). both the provide protection caps and the provide impression copings are single-use, temporary devices. if the clinician uses either of these products, the patient may experience soft tissue irritation and discomfort.
  • Action
    Customers are to inspect stock and quarantine affected units. Affected units should be returned to the sponsor. The sponsor is to confirm that all affected customers have reviewed the recall notice and return credit to the affected customers. This action has been closed-out on 26/08/2016.

Device

Provide Protection Caps and Provide Impression Copings
  • Modèle / numéro de série
    Provide Protection Caps and Provide Impression CopingsProvide Protection CapCatalogueNumber : PPC484, PPC485, PPC654, PPC655All Lots are affectedProvide Impression CopingCatalogueNumber: PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, PIC655HAll Lot Numbersare affectedARTG Number: 120308
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i 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