Events

Retiro De Equipo (Recall) de Device Recall UniCP Compression Plate System

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 Integra LifeSciences Corp..

¿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
    57380
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0955-2011
  • Fecha de inicio del evento
    2010-11-18
  • Fecha de publicación del evento
    2011-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96421
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Integra lifesciences corporation has decided to initiate a voluntary recall of the uni-comp kits due to inaccurate information relative to the recommended sterilization parameters described in the products instructions for use (ifu). the sterilization parameters noted in the uni-comp ifu were incorrect. it is noted that the sterilization recommendations in the uni-comp ifu in which the exposure.
  • Acción
    The firm, Integra, contacted the Sales Representatives on November 8, 2010 via telephone conference calls. Integra also sent a "URGENT: PRODUCT RECALL NOTIFICATION" letter dated November 9, 2010 all customers via FedEx overnight delivery. The letter described the product, problem and the action to be taken by the customers and the firm. The customers were instructed to immediately examine their inventory, QUARANTINE THE PRODUCT, and complete and return the RECALL ACKNOWLEDGMENT AND RETURN FORM via mail: Integra LifeSciences Corporation, Attn: Sandy Yates, 311 Enterprise Drive, Plainsboro, NJ 08536, fax to (609)-275-5363 or Scan and email to sandra.yates@integralife.com. The firm will have a Integra LifeSciences Corporation Sales Representative contact the customer to assist them in retrieving and returning their Uni-CP Compression Plate System to Integra. Integra will also ship replacement Uni-CP Compression Plate (Uni-CPII and Large Uni-Clip) Systems back to the customers as soon as possible at no charge. Should you have any additional questions, contact the Director of Marketing, Hindfoot-Extremity Reconstruction or your regional managers at 513-533-7929, 609-275-0500 or toll free at 800-654-2873.

Device

Device Recall UniCP Compression Plate System
  • Modelo / Serial
    Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
  • Descripción del producto
    Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC || The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.