Events

Retiro De Equipo (Recall) de LCP Drill Sleeve

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
    79021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0669-2018
  • Fecha de inicio del evento
    2017-08-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161199
  • 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
    May have difficulty attaching the drill sleeve to the plate. if the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. if the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
  • Acción
    In August of 2017 customers were mailed an URGENT FIELD SAFETY NOTICE titled "884115 - Locking Compression Plate (LCP) Drill Sleeve" requesting that customers who received product subject to recall to please contact: RA-DPYCH-flactionint@ITS.JNJ.com or call 610-719-5450. In the event that you have product requiring use: Pre-assemble the drill sleeve with the plate preoperatively. If you experience difficulty connecting the drill sleeve to the plate, use the additional 1.1 mm locking drill sleeve provided in the graphic case, or: o Align the 1.1 mm drill bit to the plate as perpendicular as possible and then drill freehand and the locking screw can be engaged in this manner. o If the drill hole must be used and no option to lock remains, a non-locking screw can be used.

Device

LCP Drill Sleeve
  • Modelo / Serial
    Lot numbers FT00227 9972971 H028400 H161606 H288454
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution to US, Canada, and Germany.
  • Descripción del producto
    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 || Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
  • 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