Events

Rappel de Device Recall Herbst Universal Nut

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Specialty Appliance Works, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70787
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1506-2015
  • Date de mise en oeuvre de l'événement
    2015-03-09
  • Date de publication de l'événement
    2015-04-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135033
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Clamp, wire, orthodontic - Product Code ECN
  • Cause
    The universal nut, a component of the orthodontic herbst appliance was made with 416 ss and not the specified 303 ss.
  • Action
    Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.

Device

Device Recall Herbst Universal Nut
  • Modèle / numéro de série
    Product No. 90885 and 90888
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
  • Description du dispositif
    M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
  • Manufacturer
    Specialty Appliance Works, Inc.

Manufacturer

Specialty Appliance Works, Inc.
  • Adresse du fabricant
    Specialty Appliance Works, Inc., 4905 Hammond Industrial Dr, Cumming GA 30041-3914
  • Société-mère du fabricant (2017)
    Specialty Appliance Works, Inc.
  • Source
    USFDA