Events

Retiro De Equipo (Recall) de Device Recall Synthes Recon Locking Aiming Arm for Lateral Entry Femoral NailsEX and the Thumb Screw for the Aim

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
    70455
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1281-2015
  • Fecha de inicio del evento
    2015-02-17
  • Fecha de publicación del evento
    2015-03-16
  • 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=133826
  • 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
    Guide, surgical, instrument - Product Code FZX
  • Causa
    For certain lots, the incorrect raw material of annealed 17-4ph stainless steel was used instead of the correct material of heat-treated 304 stainless steel. this may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.
  • Acción
    An Urgent Notice: Medical Device Recall, dated February 17, 2015, was sent to all direct consignees and sales consultants instructing them to take the following actions: Take note of the quantity of affected parts in your possession, and then follow ONE of the options for replacement of the affected product: Option 1: Call DePuy Synthes Repair Department at 1-800-288-6698 to schedule a repair for the affected products. Complete the Verification Section following the instructions provided and send a copy of the completed Verification Section to DePuy Synthes by: Fax: 866-723-2823 or Scan/e-mail: Synthes6734@stericycle.com Option 2: Call DePuy Synthes Repair Department at 1-800-288-6698 to order repair part. The replacement part will be sent directly to your facility. Questions should be directed to 610-719-5450 or a local DePuy Synthes sales consultant.

Device

Device Recall Synthes Recon Locking Aiming Arm for Lateral Entry Femoral NailsEX and the Thumb S...
  • Modelo / Serial
    Part numbers:03.010.048 and 03.010.052 with  Lot Numbers:  4874015 4874021 4927262 4954481 4963192 4874016 4874022 4944750 4957586 4963193 4784017 4899564 4944751 4957587 4972003 4874018 4899565 4954478 4957588 4972004 4874019 4927260 4954479 4957589  4874020 4927261 4954480 4963190  4922533 4922975 4981158  4922970 4923015 4981159  4922971 4977241 4981160  4922972 4977242 4981162  4922973 4981156 5035905  4922974 4981157 5035906
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). || The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
  • 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