Events

Retiro De Equipo (Recall) de Device Recall Oxford Fixed Lateral Partial Knee System

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 Biomet, 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
    75901
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0956-2017
  • Fecha de inicio del evento
    2016-12-06
  • Fecha de publicación del evento
    2017-01-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151640
  • 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, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
  • Causa
    Zimmer biomet is initiating a removal of a single lot of oxford fixed lateral bearings due to mislabeling. zimmer biomet received product complaints reporting that when the package labeled as a right was opened it actually contained a left bearing.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 6, 2016. to all affected customers for a single lot of Oxford Fixed Lateral Bearings via e-mailed letter. Zimmer Biomet received two product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing. Risks: If another bearing is not available, a delay greater than 30 minutes may occur. If the product of the incorrect orientation is implanted, premature revision may be required. Customers were instructed to review the recall notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of the Inventory Return Certification Form a. Return a digital copy within three (3) days via email to corporatequality.postmarket@zimmerbiomet.com. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Inventory Return Certification Form to Zimmer Biomet. Request a Return Authorization Number via email at rgarequest@zimmerbiomet.com . Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Inventory Return Certifictaion Form via email to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Inventory Return Certifictaion Form to Zimmer Biomet with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. 5. If after reviewing this notice you have further questions or concerns please call 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, I

Device

Device Recall Oxford Fixed Lateral Partial Knee System
  • Modelo / Serial
    Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None
  • Descripción del producto
    Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. || Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement
  • Manufacturer
    Zimmer Biomet, Inc.

Manufacturer

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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