Events

Retiro De Equipo (Recall) de Synthes XRL Medium TrialCentral Body

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
    68006
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1681-2014
  • Fecha de inicio del evento
    2014-04-08
  • Fecha de publicación del evento
    2014-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126770
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • Causa
    Two lots of the synthes xrl medium trial-central body device were incorrectly etched with the incorrect dimensions for height.
  • Acción
    Synthes sent an Urgent Notice: Medical Device Recall letter dated April 8, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action Required: Synthes has record 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. If you DO have any of the identified devices, please take the following steps: Contact your local Synthes Spine Sales Consultant to return any inventory located within your facility. 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. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Form (page 4 of this letter) to: Fax: 877-270-9246 or Scan/email: Synthes3041@stericycle.com 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 Synthes by: Fax: 877-270-9246 or Scan/email: Synthes3041@stericycle.com Note: If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.

Device

Synthes XRL Medium TrialCentral Body
  • Modelo / Serial
    Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution including the states of FL, NJ and MN.
  • Descripción del producto
    Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
  • Manufacturer
    Synthes, Inc.

Manufacturer

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