Events

Retiro De Equipo (Recall) de Device Recall WHIPKNOT Soft Tissue Cinch

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 Smith & Nephew, 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
    79700
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1536-2018
  • Fecha de inicio del evento
    2017-12-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163060
  • 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
    Fastener, fixation, biodegradable, soft tissue - Product Code MAI
  • Causa
    Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in tyvek film of pouch. a limited number of previously recalled devices were inadvertently redistributed.
  • Acción
    On 12/11/2017, recall notifications were sent to Hospital Representatives, Affiliates/Distributors, and Sales Personnel. Notified consignees were instructed to inspect inventory and quarantine any affected devices, return the completed Inventory Return Certification Form, and return the affected product. In addition to the above, Affiliates and Distributors were instructed to forwarding the recall letter to customers and asking them to return any recalled product. Consignees were instructed to contact the firm via email at FieldActions@smith-nephew.com

Device

Device Recall WHIPKNOT Soft Tissue Cinch
  • Modelo / Serial
    Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
  • Descripción del producto
    Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Dirección del fabricante
    Smith & Nephew, Inc., 130 & 120 Forbes Blvd, Mansfield MA 02048
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA