Events

Retiro De Equipo (Recall) de Device Recall Arthrex Reciprocating Saw Attachment

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 W & H DentalWerk Buermoos GMBH.

¿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
    59146
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2879-2011
  • Fecha de inicio del evento
    2011-05-24
  • Fecha de publicación del evento
    2011-07-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101341
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    Reciprocating saw attachment v 600 sr (ref: 17306210), screws can become loose or come off (the attachment) and fall into the surgical wound and may not be noticed due to its small size.
  • Acción
    Madrimed GmbH (Distributor partner) of W&H; Dentalmechanik GmbH sent a letter dated May 24, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were ask to advise their users to check the adapters thoroughly before and after each application, until the conversion of all attachments have been completed and to send all products that need to be converted to the nearest service centers. W&H; decided to convert all products that might be affected in their service centres and equip them with an additional security device. If you have any questions, call +43627462360 or email: regulatory@wh.com.

Device

Device Recall Arthrex Reciprocating Saw Attachment
  • Modelo / Serial
    Serial Numbers: 1106 through1310
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Austia, Australia, Canada, Czech Republic, Denmark, France, Germany, Italy, Kuwait, Malaysia, Netherlands, Russia, Slovakia, South Africa, Spain, Taiwan, Turkey and United Kingdom.
  • Descripción del producto
    Arthrex Reciprocating Saw Attachment || Type: V-600SR || Distributed by: Arthrex Inc., Naples, Florida United States || The system Is a modular electric system, consisting of a handpiece drive, various accessories, and a charging station for machining bones. It can be used in the following areas of application: orthopaedic and A&E; Interventions, such as osteotomies, large and small bone operations, and joint replacement operations. The charging station is intended exclusively for charging V 600 Li-Ion and V 300 LiIon rechargeable batteries
  • Manufacturer
    W & H DentalWerk Buermoos GMBH

Manufacturer

W & H DentalWerk Buermoos GMBH
  • Dirección del fabricante
    W & H DentalWerk Buermoos GMBH, 53 Ignaz-Glazer-Strasse, Burmoos Austria
  • Source
    USFDA