Events

Retiro De Equipo (Recall) de Device Recall Trauma Tubes and Plates

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, Inc..

¿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
    68818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2550-2014
  • Fecha de inicio del evento
    2014-07-22
  • Fecha de publicación del evento
    2014-08-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129074
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
  • Acción
    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.

Device

Device Recall Trauma Tubes and Plates
  • Modelo / Serial
    Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514      EXPIRATION DATE PRIOR TO 2024-07
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Trauma Tubes and Plates: || TUBE & SCP PLT 90DX150LG || TUBE & SCP PLT 90DX205LG || TUBE & SCP PLT 90DX255LG || TUBE & SCP PLT 95DX150LG || TUBE & SCP PLT 95DX205LG || TUBE & SCP PLT 95DX255LG || TUBE&SCP; PLT 130DX8H || TUBE&SCP; PLT 130DX10H || TUBE&SCP; PLT 130DX12H || TUBE&SCP; PLT 130DX14H || TUBE&SCP; PLT 135DX8H || TUBE&SCP; PLT 135DX10H || TUBE&SCP; PLT 135DX12H || TUBE&SCP; PLT 135DX14H || TUBE&SCP; PLT 140DX8H || TUBE&SCP; PLT 140DX10H || TUBE&SCP; PLT 140DX12H || TUBE&SCP; PLT 140DX14H || TUBE&SCP; PLT 145DX8H || TUBE&SCP; PLT 145DX10H || TUBE&SCP; PLT 145DX12H || TUBE&SCP; PLT 145DX14H || TUBE&SCP; PLT 150DX6H || TUBE&SCP; PLT 150DX8H || TUBE&SCP; PLT 150DX10H || TUBE&SCP; PLT 150DX12H || TUBE&SCP; PLT 150DX14H || VERSA-FX II SC TUBE PLT 90DX6H || VERSA-FX II SC TUBE PLT 90DX8H || VERSA-FXII SC TUBE PLT 90DX10H || VERSA-FXII SC TUBE PLT 90DX12H || VERSA-FXII SC TUBE PLT 90DX14H || VERSA-FXII SC TUBE PLT 95DX6H || VERSA-FXII SC TUBE PLT 95DX8H || VERSA-FXII SC TUBE PLT 95DX10H || VERSA-FXII SC TUBE PLT 95DX12H || VERSA-FXII SC TUBE PLT 95DX14H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE || VERSA-FX II STD TUBE 130DX8H || VERSA-FX II STD TUBE 130DX10H || VERSA-FX II STD TUBE 130DX12H || VERSA-FX II STD TUBE 130DX14H || VERSA-FX II STD TUBE 135DX8H || VERSA-FX II STD TUBE 135DX10H || VERSA-FX II STD TUBE 135DX12H || VERSA-FX II STD TUBE 135DX14H || VERSA-FX II STD TUBE 140DX8H || VERSA-FX II STD TUBE 140DX10H || VERSA-FX II STD TUBE 140DX12H || VERSA-FX II STD TUBE 140DX14H || VERSA-FX II STD TUBE 145DX8H || VERSA-FX II STD TUBE 145DX10H || VERSA-FX II STD TUBE 145DX12H || VERSA-FX II STD TUBE 145DX14H || VERSA-FX II STD TUBE 150DX8H || VERSA-FX II STD TUBE 150DX10H || VERSA-FX II STD TUBE 150DX12H || VERSA-FX II STD TUBE 150DX14H || VERSA-FX II KEYLESS TB 130DX8H || VERSA-FX II KEYLESS TB 135DX8H || VERSA-FX II KEYLESS TB 140DX8H || VERSA-FX II KEYLESS TB 145DX8H || VERSA-FX II KEYLESS TB 150DX8H || VERSA-FX KEYLESS 90D X 8HOLE || VERSA-FX KEYLESS 90D X 11HOLE || VERSA-FX KEYLESS 95D X 8HOLE || VERSA-FX KEYLESS 95D X 11HOLE || VERSA-FX KEYLESS 95D X 14HOLE
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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