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-1117-2016
  • 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=143668
  • 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.: 62222763 62240266 62268561 62284487 62294353 62310467 62320160 62346566 61846909 61859930 62028715 62069012 62114832 62237560 62278694 62284486 62298294 62305946 62310463 62330767 62340043 61864095 62028713 62038326 62086042 62100678 62114831 62215704 62284488 62291943 62305945 62311644 62317919 62320157 62320158 62340044 62363364 61866237 62105184 62215705 62268566 62284489 62294354 62303512 62311645 62330768 62065287 62211913 62268563 62284490 62299091 62320161 62333990 62299091N 61885871 62100679 62278695 62303703 62333992 62069011 62280472
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 19 consists of all product code: JDI and same usage: || Item no: || 765301101 CEM FEM ST 11X120 NOCOAT || 765301201 CEM FEM ST 12X125 NOCOAT || 765301301 CEM FEM ST 13X130 NOCOAT || 765301401 CEM FEM ST 14X135 NOCOAT || 765301501 CEM FEM ST 15X140 NOCOAT || 765301601 CEM FEM ST 16X145 NOCOAT || 763301300 CEM FEM ST FX 13 X 130 || 763301600 CEM FEM ST FX 16 X 145 || 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