Events

Retiro De Equipo (Recall) de Device Recall 4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screw

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
    68547
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2032-2014
  • Fecha de inicio del evento
    2014-06-12
  • Fecha de publicación del evento
    2014-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128171
  • 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
    Two lots of screws were commingled. screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. the affected product was distributed between 3/6/14 and 4/21/14.
  • Acción
    Zimmer sent an Urgent Medical Device Recall Lot specific letter dated June 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Please locate, quarantine, and return the affected product (part number 00-4840-020-00 lot number 62629432 and part number 00-2347-022-14 lot number 62628759) from all inventories. 2. Please note that any hospitals that received direct shipments of this product from Zimmer will be notified via Fed Ex. 3. Please review the list of hospital and surgeons to be provided to your territory via email. 4. Provide the name, address, and phone number of any additional hospitals or surgeons that may have received or used the affected product, or confirm that the list provided is complete. 5. Complete and return Attachment 1. 6. Ensure that a copy of the Risk Managers and Surgeons letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have questions or concerns, please contact Zimmer at 1-877-946-2761.

Device

Device Recall 4.0mm X 20mm Cancellous Screw; 4.0mm X 22mm Fully Threaded Screw
  • Modelo / Serial
    Lot No. 62629432 Lot No. 62628759
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
  • Descripción del producto
    Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
  • 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