Events

Retiro De Equipo (Recall) de Device Recall InterGro DBM Demineralized Bone Matrix

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 Michigan Orthopaedic Products, 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
    48189
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2351-2008
  • Fecha de inicio del evento
    2008-05-05
  • Fecha de publicación del evento
    2008-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70966
  • 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
    Resorbable calcium salt bone void filler device. - Product Code MQV
  • Causa
    Exposure to temperature extremes -- product was not stored under controlled conditions and may have been temperature abused. exposure to temperature extremes could cause problems with device safety (e.G. risk of infection) or problems with device effectiveness (e.G. lower healing rates if the factors or collagen in the device were affected by the temperature extremes).
  • Acción
    Three units were picked up from the consignee on or about 5/05/08. The implanting physician was verbally advised of the problem with the fourth unit. If you have any questions contact Michigan Orthopaedic Products, Inc. at (616) 249-8937.

Device

Device Recall InterGro DBM Demineralized Bone Matrix
  • Modelo / Serial
    Lots 259990 and 318630 (exp 07/2009).
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Class II Recall - Nationwide Distribution --- including the state of Michigan.
  • Descripción del producto
    InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue Bank, Tampa, Florida, EBI A Biomet Company, Parsippany, New Jersey; REF DBM002. InterGro DBM product contain human tissue (allograft bpm) and are intended for transplantation. Products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure.
  • Manufacturer
    Michigan Orthopaedic Products, Inc.

Manufacturer

Michigan Orthopaedic Products, Inc.
  • Dirección del fabricante
    Michigan Orthopaedic Products, Inc., 2905 Wilson Ave Sw Ste 100, Grandville MI 49418-1287
  • Source
    USFDA