Events

Retiro De Equipo (Recall) de Device Recall ClassOne Orthodontics Buccal SS Tubes

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 Ortho Organizers 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
    57587
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1246-2011
  • Fecha de inicio del evento
    2010-11-01
  • Fecha de publicación del evento
    2011-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96723
  • 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
    Orthodontic Tube - Product Code DZD
  • Causa
    Products were mis-labeled as nickel free.
  • Acción
    An Urgent: Product Recall Notice letter, dated November 1, 2010 was sent to consignees at the distribution level who received recalled products. Consignees were instructed to do the following: 1) Carry out a physical count of current inventory and record this data on the business reply card provided with this notice. Return the enclosed Reply Card with the amount remaining inventory to Ortho Organizers, Inc., Carlsbad, CA 92008 within 10 days of receipt of this notification. 2) Immediately cease distribution/use of this product and remove from your shelves. 3) Notify all of your retail customers with the Urgent: Product Recall Notice (Retail Level) letter who purchased the affected item numbers from you that the affected items are stainless steel and contain nickel. 4) Contact your sales representative to return any unused items. Return any unused product within 30 days. Please clearly mark the return carton Recall Material Enclosed. Ortho Organizers shall accept any product covered by this recall and credit your account for all product and shipping costs.

Device

Device Recall ClassOne Orthodontics Buccal SS Tubes
  • Modelo / Serial
    Buccal SS Tubes Item Numbers: #351-327 (all lots) #351-328 (all lots) #351-418 (all lots) #351-427 (all lots) #351-428 (all lots) #351-459 (all lots) #351-460 (all lots)
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of CA, CO, IL, LA, MI, MN, PA & TX and countries of CA (Canada), BE (Belgium), NO (Norway), and CO (Columbia).
  • Descripción del producto
    ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); || ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; || ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; || ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; || ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; || ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; || ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.
  • Manufacturer
    Ortho Organizers Inc

Manufacturer

Ortho Organizers Inc
  • Dirección del fabricante
    Ortho Organizers Inc, 1822 Aston Ave, Carlsbad CA 92008-7306
  • Empresa matriz del fabricante (2017)
    Henry Schein Inc
  • Source
    USFDA