Events

Retiro De Equipo (Recall) de Device Recall Zimmer

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 Manufacturing B.V..

¿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
    72900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1168-2016
  • Fecha de inicio del evento
    2016-01-11
  • Fecha de publicación del evento
    2016-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143897
  • 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, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Causa
    As a result of the insufficient sealer calibration data for product packaged in firm's building ii between august 2010 and april 2013. the affected products are sterile.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

Device

Device Recall Zimmer
  • Modelo / Serial
    lot no.: 61661156 61966578 62225735 61873650 61962858 62137227 62137228 62240762 62340060 62340060N 61820823 61881193 61957419 61962855 62172047 62175238 62234460 62262787 62291935 62298291 62298292 62310454 62314656 62340058 62298291N 62310454N 62314656N 62340058N 61878467 61881194 61883397 61886939 61899754 61968010 62221008 62284504 62285272 62291937 62291937N 61822322 62032180 62260128 62304808 62340062 62358896 62304808N 62340062N 61813932 61820819 61980168 62205493 62240263 62240771 62240772 62240773 62240774 62282932 62291138 62291938 62296576 62299089 62340063 62296576N 62340063N 61866252 62257147 62303509 62340064 62340064N 61814493 61976178 62046502 62240775 62312492 61679898 61995953 61995956 61995957 61995958 61885901 62046499 62211984 370462 61980171
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 70 consists of all product under product code: JDI and same usage: || Item no: || 785701000 VERSYS HERITAGE FEM STEM || 785701100 VERSYS HERITAGE FEM STEM || 785701200 VERSYS HERITAGE FEM STEM || 785701300 VERSYS HERITAGE FEM STEM || 785701320 VERSYS HERITAGE FEM STEM || 785701400 VERSYS HERITAGE FEM STEM || 785701420 VERSYS HERITAGE FEM STEM || 785701500 VERSYS HERITAGE FEM STEM || 785701520 VERSYS HERITAGE FEM STEM || 785701600 VERSYS HERITAGE FEM STEM || 785701700 VERSYS HERITAGE FEM STEM || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.

Manufacturer

Zimmer Manufacturing B.V.
  • Dirección del fabricante
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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