Events

Retiro De Equipo (Recall) de Device Recall NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR

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 Zimmer 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
    58180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2173-2011
  • Fecha de inicio del evento
    2011-03-14
  • Fecha de publicación del evento
    2011-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98606
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Causa
    The firm is initiating a recall due to the potiential for the spring clip to break off during use and fall into the surgical site. the firm has received 24 complaints of the spring breaking, four of which were reported that the patient had to undergo additional x-rays to ensure the fractured clip had not been left in-vivo.
  • Acción
    The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" notice dated March 14, 2011 to its Consignees/customers. The letter described the product, problem, and the actions to be taken. The customers were instructed to stop using the device and quarantine immediately; carry out a physical count of all affected product in their territory and record this data on the Inventory Return Certification Form and fax to (574) 372-4265; ensure they have provided acknowledgement via "email return receipt" upon receiving notification; return the recalled product along with the completed Inventory Return Certification Form and Sterilization Certification Form to: Zimmer Distribution Center, Attn: Product Service, 1777 West Center Street, Warsaw, IN 46580-Note: The instrument must be returned even if the spring clip is not missing from the instrument; and if they distributed these affected lots further, provide a copy of this letter to the those customers when they implement these recall instructions. The letter stated that a new or refurbished instrument with a redesigned spring clip will be provided as replacement for the recalled device. For shipping assistance, questions or assistance in notifying your accounts about the recall, please contact Zimmer, Inc. at 1-800-613-6131.

Device

Device Recall NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR
  • Modelo / Serial
    61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596 61675231, 61691488, 61701224 and 61708918.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide)including states of: HI, CA, NY, MI, IN, GA, FL, WI, MN, NJ, IL, VA, TX, NC, PA, MS, WA, OR, OH, KS, TN, NH, AZ, NV, UT and AK and countries of : Australia, Canada, China, Germany, India, Japan, Singapore and Sweden.
  • Descripción del producto
    NEXGEN COMPLETE KNEE SOLUTION FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, NONSTERILE, REF 00-5901-026-00, Zimmer UK, Ltd., Zimmer Warsaw, IN. || Intended use: The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA