Retiro De Equipo (Recall) de Device Recall Synthes

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 Synthes, 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
    67261
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1057-2014
  • Fecha de inicio del evento
    2014-01-07
  • Fecha de publicación del evento
    2014-02-20
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-08-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    The synthes driving cap/threaded can bind in the im nail radiolucent insertion handles when assembled becoming difficult to separate.
  • Acción
    Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form (page-3 of this letter) with the product to: "Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affected product has been located. :Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. "Return the documents to DePuy Synthes by: " Fax: 877-271-1473 or " Scan/email: FieldAction@synthes.com If you have any questions,please call 610-719-5450. Thank you for your attention to this issue.

Device

  • Modelo / Serial
    Part No. 03.010.523, Lot Nos. 8279162 & 8429004
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) Distribution.
  • Descripción del producto
    Synthes Driving Cap/Threaded || Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA