Events

Retiro De Equipo (Recall) de PROXIMATE and Transtar

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 Ethicon Endo-Surgery 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
    62879
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0057-2013
  • Fecha de inicio del evento
    2012-08-03
  • Fecha de publicación del evento
    2012-10-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111929
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Ethicon endo-surgery initiated this voluntary global recall for specific production lots of proximate¿ pph hemorrhoidal circular stapler and accessories 33mm (pph01 and pph03) and transtar¿ circular stapler procedure set (str10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.
  • Acción
    Ethicon Endo-Surgery sent an Urgent Device Recall letter dated August 3, 2012 via overnight, Federal Express UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return per the instructions provided. Customers were advised to complete the Business Reply Form (BRF) and fax it to Stericycle at 1-888-628-0733 within 3 business days, even if you do not have affected product. The letter states that Ethicon Endo-Surgery will issue credit for recalled products returned by November 5, 2012. Any product returned after November 5, 2012 will not be eligible for credit. For clinical or product support call 1-800-873-3636, option 6 or contact your local sales representative and reference Event 7283.

Device

PROXIMATE and Transtar
  • Modelo / Serial
    PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017;  PPH03: 494 lots; 144,963 pieces; Expiration date March 2016 - June 2017;  STR10: 3 lots; 432 pieces; Expiration date Sept 2016 - Oct 2016
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of: ARGENTINA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MALAYSIA, MEXICO, NEPAL, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, and YEMEN. There was one Canadian consignee and 43 U.S. Government consignees.
  • Descripción del producto
    Hemorrhoidal Circular Stapler and Accessories 33mm || Product Usage: || The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Dirección del fabricante
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA