Events

Retiro De Equipo (Recall) de SHARPOINT IQ Geometry Slit Knives

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 Surgical Specialties Puerto Rico Inc. dba Angiotech PR 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
    62945
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0202-2013
  • Fecha de inicio del evento
    2012-08-15
  • Fecha de publicación del evento
    2012-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112325
  • 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
    Blade, scalpel - Product Code GES
  • Causa
    Potential for bent tips.
  • Acción
    Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product. Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807. For questions regarding this recall call 787-658-1800.

Device

SHARPOINT IQ Geometry Slit Knives
  • Modelo / Serial
    M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
  • Descripción del producto
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" || Ophthalmic surgery
  • Manufacturer
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.

Manufacturer

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
  • Dirección del fabricante
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc., Rd 459 Km 0.6, Montana Industrial Park, Aguadilla PR 00605
  • Empresa matriz del fabricante (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA