Retiro De Equipo (Recall) de Device Recall Distalizer Lock Nut 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 Allesee Orthodontic Appliances.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Retainer, screw expansion, orthodontic - Product Code DYJ
  • Causa
    The lock nut component of the jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.
  • Acción
    An advisory letter dated January 10, 2014 was sent to customers. The letter titled "ATTENTION: FIELD CORRECTIVE ACTION", informed customers the reason for recall, product description and devices affected dates of manufacturer, potential hazard, a photo comparison of a lock nut with screw collar and lock nut with no screw collar, instructions to the customers, and contact information. The letter was accompanied by an acknowledgement form titled "DISTALIZER JET LOCK NUT ACKNOWLEDGEMENT FORM". A follow up letter dated February 24, 2014 on March 7, 2014 to customers. This letter addresses the issue of the replacement screws as a follow up to the initial January 10, 2014 letter. The follow up letter, titled "ATTENTION: MEDICAL DEVICE RECALL" is dated Februray 24, 2014, refrences the January 10, 2014 letter that AOA sent, attaches the letter for reference, and informs customers that "AOA is now offering the option to obtain a Lock Nut with Screw Collar to replace within devices determined to be affected by this recall". The follow up letter informs customers of the reason for recall, the description and manufacturing dates of product affected, instructions to follow, and contact information. The customers were instructed to 1) continue to monitor the patient during the time of treatment; or 2) remove the device from the patient's mouth and return it to AOA for evaluation/replacement; or 3) request a replacement Lock Nut Screw with collar by contacting our Customer Support Department at 1-800-262-5221, and complete and return the attached acknowledgement form titled "DISTALIZER JET LOCK NUT RECALL ACKNOWLEDGEMENT FORM" via fax to 262-886-6879. If you have any questions, contact the Customer Support Department at 1-800-262-5221.


  • Modelo / Serial
    All Devices/Codes Manufactured from August 28, 2013 to November 6, 2013
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution: US (nationwide) and the country of : Canada.
  • Descripción del producto
    AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.
  • Manufacturer


  • Dirección del fabricante
    Allesee Orthodontic Appliances, 13931 Spring St, Po Box 725, Sturtevant WI 53177-1250
  • Source