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-1136-2016
  • 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=143746
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • 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.: 61793328 62253390 61641813 62194666 61993625 62262085 62313056 62313056N 62021140 62312364 62312364N 61817404 61809837 61851878 61987145 62165485 62244841 62244854 61763549 61826386 61851889 61968098 62114111 62114112 62172486 61804389 61841502 61872521 61962448 61983689 62137121 62244852 61665045 61841504 62031683 62137150 62244853 61809838 62306323 62306323N 61830462 61809839 62189554 61804722 61830471 62165499 62165501 62189558 61809843
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 38 consists of all product under product code: HSB and same usage: || Item no: || 225303255 INTERLOCKING IM SCREW LG || 225303555 INTERLOCKING IM SCREW LG || 225303755 INTERLOCKING IM SCREW LG || 225307055 INTERLOCKING IM SCREW LG || 225302742 INTERLOCKING IM SCREW MED || 225303242 INTERLOCKING IM SCREW MED || 225307042 INTERLOCKING IM SCREW MED || 225302737 INTERLOCKING IM SCREW SML || 225303237 INTERLOCKING IM SCREW SML || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • 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