Events

Retiro De Equipo (Recall) de "LOCATOR Abutment for 5.7 ScrewVent Compatibles"

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zest Anchors Inc.

¿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
    48645
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0298-2009
  • Fecha de inicio del evento
    2008-04-09
  • Fecha de publicación del evento
    2008-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71791
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Endosseous, root-form implant - Product Code DZE
  • Causa
    The recall was initiated after the firm discovered through a customer complaint that the locator abutments for 5.7 screw-vent & compatibles do not fit properly in all sizes of the zimmer dental 5.7mm diameter tapered screw-vent implants (tsv6b8, tsv6b10, tsv6b11, tsv6b13, tsv6b16, tsv6h8, tsv6h10, tsv6h11, tsv6h13 and tsv6h16). the locator abutment bottoms out in the pilot hole of these implants c.
  • Acción
    The recall notification letter (Recall Notice) was sent to consignees on April 23,2008. The letter includes the following information on how to handle the recall. It is very important that you determine the use of the Locator Abutment(s) as follows, mark the appropriate box, ,and return this letter to Zest Anchors, Inc. in the stamped, self-addressed envelope: 1. The Locator Abutment(s) listed above WERE NOT used on any Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants. THE FIT IS CORRECT AND NO ACTION IS NECESSARY. 2. The Locator Abutment(s) listed above WERE used on a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE R PLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. and 3. We have current STOCK of the Locator Abutment(s) listed above with planned use for a Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implant. PLEASE CONTACT OUR DENTAL OFFICE TO ARRANGE THE REPLACEMENT OF THE ABUTMENT WITH A NEWLY DESIGNED LOCATOR ABUTMENT. For questions or additional information, contact Zest Anchors, Inc. at 800-262-2310 or 760-743-7744.

Device

"LOCATOR Abutment for 5.7 ScrewVent Compatibles"
  • Modelo / Serial
    Product Codes: 8190 (1.0 mm), 8191 (2.0 mm), 8192 (3.0mm), 8193 (4.0mm), 8194 (5.0 mm) and 8195 (6.0mm).
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including USA and countries of Spain, Canada, Australia and South Africa.
  • Descripción del producto
    "LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. || The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.
  • Manufacturer
    Zest Anchors Inc

Manufacturer

Zest Anchors Inc
  • Dirección del fabricante
    Zest Anchors Inc, 2061 Wineridge Pl, Escondido CA 92029-1947
  • Empresa matriz del fabricante (2017)
    Zest Anchors Inc.
  • Source
    USFDA