Events

Retiro De Equipo (Recall) de Synthes Threaded Plate Holder Long for 3.5mm Locking Hold

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 (USA) Products LLC.

¿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
    72360
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0192-2016
  • Fecha de inicio del evento
    2015-10-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140745
  • 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
    Mesh, surgical, metal - Product Code EZX
  • Causa
    The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a small fragment plate.
  • Acción
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 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, address, telephone number and signature in the spaces provided. " Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Even if you do not have any product. " Send a copy of the completed Verification Section by: Fax: 844-721-3048 or Scan/email: Synthes4704@stericycle.com. " Note: If the Verification Section 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 3 of the notification. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Device

Synthes Threaded Plate Holder Long for 3.5mm Locking Hold
  • Modelo / Serial
    Threaded Plate Holder-Long for 3.5mm Locking Hole  Part Numbers Lot Numbers  324.031 8225613
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US (nationwide) and country of: Canada.
  • Descripción del producto
    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. || The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Dirección del fabricante
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA