Events

Rappel de Device Recall Spirit MB Brackets

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 Ormco Corporation.

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
    60118
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0200-2012
  • Date de mise en oeuvre de l'événement
    2011-05-18
  • Date de publication de l'événement
    2011-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104468
  • 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
    Bracket, plastic, orthodontic - Product Code DYW
  • Cause
    Ormco corporation is voluntarily recalling three lots of spirit mb brackets due to a manufacturing error.
  • Action
    Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.

Device

Device Recall Spirit MB Brackets
  • Modèle / numéro de série
    Lot #02112284
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
  • Description du dispositif
    Spirit MB Brackets, part #494-1210. || The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation
  • Adresse du fabricant
    Ormco Corporation, 1332 S Lone Hill Ave, Glendora CA 91740
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA