Events

Retiro De Equipo (Recall) de Device Recall Bariatric Target Ring (Nitinol)

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 Kapp Surgical Instrument 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
    59024
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2753-2011
  • Fecha de inicio del evento
    2011-05-24
  • Fecha de publicación del evento
    2011-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-02-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100856
  • 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
    Marker, radiographic, implantable - Product Code NEU
  • Causa
    During an fda inspection on 3/21/11 - 3/22/11 at kapp surgical an uncontrolled instruction for use was discovered which contained sterilization parameters which differed from the instructions contained in the device master record. kapp surgical decided to conduct the recall because we cannot be sure that incorrect instructions were not shipped.
  • Acción
    Kapp Surgical Instrument, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and quarantine any product affected by this recall. The firm will make arrangements for returning the products. Replacements will be made by Kapp Surgical. Questions about this recall are directed to the QA Manager at 800-282-5277.

Device

Device Recall Bariatric Target Ring (Nitinol)
  • Modelo / Serial
    M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.
  • Descripción del producto
    Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. || It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.
  • Manufacturer
    Kapp Surgical Instrument Inc

Manufacturer

Kapp Surgical Instrument Inc
  • Dirección del fabricante
    Kapp Surgical Instrument Inc, 4919 Warrensville Center Rd, Warrensville Heights OH 44128-4353
  • Empresa matriz del fabricante (2017)
    Kapp Surgical Instrument Inc.
  • Source
    USFDA