Events

Retiro De Equipo (Recall) de Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.

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 Orthopaedic Surgical Products.

¿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
    30476
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0388-05
  • Fecha de inicio del evento
    2004-10-27
  • Fecha de publicación del evento
    2005-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35967
  • 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
    Tourniquet, Pneumatic - Product Code KCY
  • Causa
    The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
  • Acción
    Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.

Device

Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder...
  • Modelo / Serial
    Cat #60-7075-007-00, Lot #60171355. On 02/11/2005 the firm expanded the recall to include all cuffs including the following codes:Cat #60-7075-006-00, Lot #60154126, Single Port Cuff Cat #60-7075-056-00, Lot #60135939, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-004-00, Lot #60144536, Single Port Cuff, Cat #60-7075-007-00, Lot #60156860, Single Port Cuff, Cat #60-7075-052-00, Lot #60121031, Single Port Cuff, Cat #60-7075-001-00, Lot #60132141, Single Port Cuff, Cat #60-7075-003-00, Lot #60175349, Single Port Cuff, Cat #60-7075-006-00, Lot #60168614, Single Port Cuff, Cat #60-7075-003-00, Lot #60180950, Single Port Cuff, Cat #60-7075-006-00, Lot #60180452, Single Port Cuff, Cat #60-7075-054-00, Lot #60129625, Single Port Cuff, Cat #60-7075-004-00, Lot #60162833, Single Port Cuff, Cat #60-7075-007-00, Lot #60184637, Single Port Cuff, Cat #60-7075-006-00, Lot #60191899, Single Port Cuff, Cat #60-7075-053-00, Lot #60155642, Single Port Cuff, Cat #60-7075-005-00, Lot #60173812, Single Port Cuff, Cat #60-7075-001-00, Lot #60176467, Single Port Cuff, Cat #60-7070-003-00, Lot #60191898, Single Port Cuff, Cat #60-7075-003-00, Lot #60205584, Single Port Cuff, Cat #60-7075-003-00, Lot #60210874, Single Port Cuff, Cat #60-7075-006-00, Lot #60202395, Single Port Cuff, Cat #60-7075-056-00, Lot #60172186, Single Port Cuff, Cat #60-7075-053-00, Lot #60162834, Single Port Cuff, Cat #60-7075-054-00, Lot #60189989, Single Port Cuff, and Cat #60-7075-002-00, Lot #60180458, Single Port Cuff.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, Demark, Germany
  • Descripción del producto
    Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
  • Manufacturer
    Zimmer Orthopaedic Surgical Products

Manufacturer

Zimmer Orthopaedic Surgical Products
  • Dirección del fabricante
    Zimmer Orthopaedic Surgical Products, 2021 Old Mountain Rd, Statesville NC 28625-1630
  • Source
    USFDA