Events

Retiro De Equipo (Recall) de Device Recall Orthovita(R) Cortoss(TM) Delivery Gun

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 Orthovita, 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
    58478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3188-2011
  • Fecha de inicio del evento
    2011-03-31
  • Fecha de publicación del evento
    2011-09-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99433
  • 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
    Dispenser, cement - Product Code KIH
  • Causa
    Recalling firm has discovered through internal testing that the cortoss(tm) delivery gun may abrade its packaging material under certain transportation and handling conditions. this abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. although t the cortoss(tm) delivery gun is provided in double pouches and there have been no report.
  • Acción
    Orthovita sent an "URGENT FIELD SAFETY NOTICE" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost. For any questions regarding this notice call 484-323-8860.

Device

Device Recall Orthovita(R) Cortoss(TM) Delivery Gun
  • Modelo / Serial
    Part Number 2110-0008: Lot numbers affected are A812057, A902032, A902063, A904005, A905009, A905039, A906004, A910016, A910021, A912029, A912039, and A1001020. No other lot numbers are affected.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. Government accounts include Bethesda Naval Center, 8901 Rockville Pike, Bethesda, MD; Lackland Air Force Base, 2200 Berquist Drive, Suite 1, Lackland AFB, TX; Hunter Holmes McGuire VA Hospital 1201 Broad Rock Blvd., Richmond, VA; Madigan Army Medical Center, Madigan Army Medical Center, Tacoma, WA; Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC; VA Medical Center, 1481 W. 10th St., Indianapolis, IN; VA Hospital of Palo Alto, 3801 Miranda Ave., Palo Alto, CA; VA Loma Linda Healthcare System, 11201 Benton Street, Loma Linda, CA; and VA Medical Center/NY Harbor Healthcare, NY, NY.
  • Descripción del producto
    Orthovita(R) Cortoss(TM) Delivery Gun || Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material
  • Manufacturer
    Orthovita, Inc.

Manufacturer

Orthovita, Inc.
  • Dirección del fabricante
    Orthovita, Inc., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA