Events

Retiro De Equipo (Recall) de TRIGEN INTERTAN NAIL

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 Smith & Nephew 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
    68043
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1636-2014
  • Fecha de inicio del evento
    2014-04-04
  • Fecha de publicación del evento
    2014-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126851
  • 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
    Nail, fixation, bone - Product Code JDS
  • Causa
    A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
  • Acción
    The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.

Device

TRIGEN INTERTAN NAIL
  • Modelo / Serial
    TRIGEN INTERTAN NAIL:  (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190   (2) REF 71675202, Lot Numbers: 13LT36308, 13LT36549, 13LT37011, 13MT37348, 14AT38750  (3) REF 71675203, Lot Numbers: 13KT36106, 13LT36596, 14AT38494  (4) REF 71675204, Lot Numbers: 13LT36597, 13LT37012, 14AT38495, 14AT38660  (5) REF 71675205, Lot Number 13LT36598  (6) REF 71675207, Lot Numbers: 13LT363089, 13LT36310, 13LT36599, 13LT37058, 13LT37059, 13LT37063, 13MT37264, 13MT37265, 13MT37266, 13MT37329, 13MT37349, 13MT37350, 13MT37669, 13MT37671, 13MT37672  (7) REF 71675208, Lot Numbers: 13LT36311, 13LT36312, 13LT36600, 13LT37060, 13LT37061, 13MT37351, 13MT37666, 13MT37963  (8) REF 71675211, Lot Number 13LT36313
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
  • Descripción del producto
    TRIGEN INTERTAN NAIL: || (1) REF 71675201, 10 MM X 18 CM, 125 degree, || (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, || (3) REF 71675203, 13 MM X 18 CM, 125 degree, || (4) REF 71675204, 10 MM X 20 CM, 125 degree, || (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, || (6) REF 71675207, 10 MM X 18 CM, 130 degree, || (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, || (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, || Smith & Nephew, Inc. Orthopedic fixation device.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Dirección del fabricante
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Empresa matriz del fabricante (2017)
    Smith & Nephew plc
  • Source
    USFDA