Events

Retiro De Equipo (Recall) de In Situ Bender Cutter Kit Wide Sterile

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 Synthes Spine.

¿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
    51702
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1640-2009
  • Fecha de inicio del evento
    2009-04-03
  • Fecha de publicación del evento
    2009-05-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81434
  • 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
    Bone Fixation Plate - Product Code HRS
  • Causa
    Sterility may be compromised due to a ineffective package design.
  • Acción
    All affected Synthes DMF Sales Consultants were notified of the Medical Device Recall by an Urgent: Medical Device Recall letter notification which was sent via USPS certified mail on 4/6/09. The letter stated the problem and risk. The firm recommended that patients who have had a surgical procedure in which these products were utilized be monitored for signs/symptoms of infection for a period of six months following surgery. If customers have any of the identified devices, they are to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number; complete the form; and return the letter with the recalled product to the address provided. Customers that do not have the identified product, are to complete the attached form and return the document to the address provided acknowledging their receipt of the recall information. Questions should be directed to their Synthes CMF Sales Consultant.

Device

In Situ Bender Cutter Kit Wide Sterile
  • Modelo / Serial
    Lot numbers TM00119 exp 6/30/05, TM00122 exp 7/31/04, TM00124 exp 7/31/04, TM00128 exp 9/30/05, TM00150 exp 10/31/06, TM00155 exp 3/9/07, TM00160 exp 12/29/08, TM00172 exp 3/30/09, TM00197 exp 7/31/09, TM00220 exp 9/7/09, TM00221 exp 9/7/09, TM00260 exp 3/10/10, TM00271 exp 4/28/10, TM00295 exp 10/10/10, TM00315 exp 2/28/11, TM00322 exp 4/13/11, 4859489 exp 7/30/05, 4859490 exp 6/30/05, 4859492 exp 7/31/05, and TM00341 exp 3/12/12.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the country of Canada.
  • Descripción del producto
    In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S || Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in adults and children.
  • Manufacturer
    Synthes Spine

Manufacturer

Synthes Spine
  • Dirección del fabricante
    Synthes Spine, 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA