Events

Retiro De Equipo (Recall) de Stryker Biotech

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 Stryker Biotech.

¿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
    56962
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1727-2011
  • Fecha de inicio del evento
    2010-10-25
  • Fecha de publicación del evento
    2011-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95046
  • 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
    Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde - Product Code OJZ
  • Causa
    A change to the preparation for use section was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved.
  • Acción
    The firm, Stryker Biotech, sent a "Medical Device Correction" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty. If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at PVG@stryker.com.

Device

Stryker Biotech
  • Modelo / Serial
    OP-1 Putty, Catalog #300-50 Lot Number Expiry Date FC0902004 8/31/2009 FC0902005 8/31/2009 FC0903002 8/31/2009 FC0903004 8 /31/2009 FC0903005 8/31/2009 FC0905003 3/31/2010 FC0905005 3/31/2010 FC0906002 4/30/2010 FC0907002 4/30/2010 FC0907005 4/30/2010 FC0908001 4/30/2010 FC0908003 2/28/2010 FC0908004 4/30/2010 FC0908006 4/30/2010 FC0909005 4/30/2010  OP-1 Putty, catalog #300-55 Lot Number Expiry Date FC0909002 8/31/2010 FC0909003 8/31/2010 FC0909004 8/31/2010 FC0909008 8/31/2010 FC0909009 8/31/2010 FC0909012 8/31/2010 FC0909013 8/31/2010 FC0910003 8/31/2010 FC0910004 8/31/2010 FC0911001 8/31/2010 FC0911002 8/31/2010 FC0912002 8/31/2010 FC0912004 8/31/2010 FC1001002 8/31/2010 FC1002001 8/31/2010 FC1002004 8/31/2010 FC1002005 8/31/2010 FC1003001 10/31/2010 FC1003003 10/31/2010 FC1004001 10/31/2010 FC1005001 10/31/2010 FC1005002 10/31/2010 FC1005003 10/31/2010 FC1006001 10/31/2010 FC1007001 1/31/2012 FC1007004 1/31/2012 FC1007005 1/31/2012 FC1007006 1/31/2012 FC1007007 1/31/2012 FC1008001 1/31/2012 FC1008002 1/31/2012 FC1009002 1/31/2012 FC1009004 1/31/2012 FC1009005 1/31/2012
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    HDE
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Stryker Biotech OP-1 Putty (OP-1, BMP-7, bone morphogenetic protein) || "Catalog numbers: 300-50, 300-55 || OP-1 Putty is authorized by Federal law for use as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion, for whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion. Examples of compromising factors include osteoporosis, smoking and diabetes.
  • Manufacturer
    Stryker Biotech

Manufacturer

Stryker Biotech
  • Dirección del fabricante
    Stryker Biotech, 35 South St, Hopkinton MA 01748-2218
  • Source
    USFDA