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-1154-2016
  • 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=143881
  • 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
    Screw, fixation, bone - Product Code HWC
  • 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.: 62127759 62196525 61955423 62289877 62052696 62052696N 62144719 61930078 62138079 62052697 61960862 62253596 62253596N 62027415 62052698 62052699 61567438 61966260 61966261 61966262 61966263 61966264 61966265 61641810 61903337 61903338 61898112 62138080 61903334 61903335 61903336 61966254
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Product 56 consists of all product under product code: HWC and same usage: || Item no: || 47234702032 PERI SCR 3.5MM X 32MM STE || 47234702018 PERI SCR. 3.5MM X 18MM ST || 47234702020 PERI SCR. 3.5MM X 20MM ST || 47234702022 PERI SCR. 3.5MM X 22MM ST || 47234702026 PERI SCR. 3.5MM X 26MM ST || 47234702030 PERI SCR. 3.5MM X 30MM ST || 47234702034 PERI SCR. 3.5MM X 34MM ST || 47234702036 PERI SCR. 3.5MM X 36MM ST || 47234702042 PERI SCR. 3.5MM X 42MM ST || 47234702046 PERI SCR. 3.5MM X 46MM ST || 47234702050 PERI SCR. 3.5MM X 50MM ST || 47234702080 PERI SCR. 3.5MM X 80MM ST || 47234702085 PERI SCR. 3.5MM X 85MM ST || 47234702155 PERI SCR. 4.0MM X 55MM || 47234702160 PERI SCR. 4.0MM X 60MM || 47234702210 PERI SCR. 4.0MMX10MM FULL || 47234702212 PERI SCR. 4.0MMX12MM FULL || 47234702214 PERI SCR. 4.0MMX14MM FULL || 47234702216 PERI SCR. 4.0MMX16MM FULL || 47234702260 PERI SCR. 4.0MMX60MM FULL || 47234702336 PERI SCR. 4.5MM X 36MM || 47234702338 PERI SCR. 4.5MM X 38MM || 47234712440 PERI SCR. 6.5MM X 140MM || 47234702670 PERI SCR. 6.5MM X 70MM || 47234702122 PERI. SCR 4.0MM X22MM || 47234702124 PERI. SCR 4.0MM X24MM || 47234702126 PERI. SCR 4.0MM X26MM || 47234702128 PERI. SCR 4.0MM X28MM || Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • 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