Events

Retiro De Equipo (Recall) de Provide Protection Caps and Provide Impression Copings

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomet 3i Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01113-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01113-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “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