Events

Retiro De Equipo (Recall) de Device Recall Brand Name: Vector TAS 8mm Screw.

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 Ormco/Sybronendo.

¿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
    66173
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2194-2013
  • Fecha de inicio del evento
    2013-07-12
  • Fecha de publicación del evento
    2013-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121615
  • 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
    Implant, endosseous, orthodontic - Product Code OAT
  • Causa
    Ormco corporation is voluntarily recalling one lot of 8 mm vector tas screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Acción
    Ormco sent an "Urgent Medical Device Recall letter dated July 12, 2013, via USPS 1st class mail, along with a return form to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed of the recall, with product description, product codes, ship dates, contact information and instructions to return any affected product identified in stock, Additionally, doctors are instructed to proceed with treatment if the screw has already been placed and to take special care not to over-torque the screw upon removal. Periodic effectiveness checks will be conducted in order to follow up with non-responders. Please fax this acknowledgement form to the the following number to confirm receipt of this notification whether or not you have any affected products. (714) 288-4603

Device

Device Recall Brand Name: Vector TAS 8mm Screw.
  • Modelo / Serial
    Lot Number 112911: 8 MM Vector TAS Screw, Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient), Part Number 601-0010
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.
  • Descripción del producto
    Brand Name: Vector TAS 8mm Screw. || The Device Listing Number is E670535. || Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Dirección del fabricante
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA