Events

Retiro De Equipo (Recall) de Device Recall Collagen Meniscus Implant

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 Stryker Corporation.

¿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
    79030
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0974-2018
  • Fecha de inicio del evento
    2018-01-25
  • 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=161212
  • 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
    Scaffold, partial medial meniscal defects extending into the red/white zone, resorbable bovine collagen - Product Code OLC
  • Causa
    The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
  • Acción
    The international Stryker site was notified by email on 1/25/2018. Customers are instructed to: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Review Part Numbers (4600, 4601, 4607, and 4612) for affected lot numbers. Please determine if you have the affected product in stock. Response is required. 3. If no product is found, notify your local Stryker office.4. If you do have product, segregate the product and call your local Stryker office to arrange for product return and issuance of credit.

Device

Device Recall Collagen Meniscus Implant
  • Modelo / Serial
    Serial/Lot Number(s) Affected: 4600: 15J456; 4601: 16A463, 16G470, 17F510; 4607: 16A461, 16D465, 16E467, 16F468, 17E506, 17E507; 4612: 16A458, 16A459, 17D489, 17E503, 17E504
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Netherlands
  • Descripción del producto
    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant || Product Usage: || The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.
  • Manufacturer
    Stryker Corporation

Manufacturer

Stryker Corporation
  • Dirección del fabricante
    Stryker Corporation, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA