Events

Retiro De Equipo (Recall) de Device Recall CollaGuide Collagen Dental Membrane

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 Kensey Nash 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
    61819
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1623-2012
  • Fecha de inicio del evento
    2012-02-28
  • Fecha de publicación del evento
    2012-05-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109174
  • 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
    Barrier, animal source, intraoral - Product Code NPL
  • Causa
    Recall has been initiated due to concerns regarding the sterility of the product. the firm initiated the recall because of use of inadequately sterilized product might result in patient infection,.
  • Acción
    Reimser, Inc. sent an "URGENT PRODUCT RECALL-COLLAGUIDE COLLAGEN DENTAL MEMBRANE" letter dated March 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to cease use, secure and quarantine affect product. Additionally, a Recall Acknowledgement Form was attached for customers to complete and return to the firm via fax to 1-800-505-4982. Contact the firm at 484-713-2197 for questions regarding this recall.

Device

Device Recall CollaGuide Collagen Dental Membrane
  • Modelo / Serial
    30mm X 40mm Part number 20650-03 Lot # 91026 Expiration date 07/31/12 Lot # 92340 Expiration date 10/31/12 Lot # 94766 Expiration date 03/31/13 Lot # 95912 Expiration date 05/31/13 Lot # 97041 Expiration date 08/31/13 Lot # 98321 Expiration date 11/30/13 Lot # 84506 Expired Lot # 86568 Expired Lot # 89496 Expired
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. || Colla Guide Collagen Membrane Distributed by: Riemser Inc., PO Box 12339 Research Triangle Park, NC 27709-2339 USA Kensey Nash Corporation, 735 Pennsylvania Drive, Exton, PA 19341 USA QTY 1 Sterile Rx only || 30mm X 40mm REF 20650-03 6280-03 Rev.AE || Quantity 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30¿C (86¿F) Do not re-use. || CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
  • Manufacturer
    Kensey Nash Corp

Manufacturer

Kensey Nash Corp
  • Dirección del fabricante
    Kensey Nash Corp, 735 Pennsylvania Dr, Exton PA 19341
  • Empresa matriz del fabricante (2017)
    Royal DSM NV
  • Source
    USFDA