Events

Rappel de Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,

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
    61221
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1136-2012
  • Date de mise en oeuvre de l'événement
    2009-02-13
  • Date de publication de l'événement
    2012-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107601
  • 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, metal, orthodontic - Product Code EJF
  • Cause
    The recall was initiated because ormco has confirmed that manufacturing error resulted in the orthos cm brackets being incorrectly manufactured with a torque of -9¿. the packaging was labeled with +9¿ torque; however the brackets contained inside the packaging are actually orthos cm brackets with a torque of -9¿.
  • Action
    Ormco Corporation sent an Urgent Field Safety Notice dated February 13, 2009, to all affected customers. The recall communication for consignees in the United States, Canada, Colombia, HongKong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa and Croatia was sent on February 13, 2009 via USPS First Class Mail. The recall communication for consignees in Japan was sent on February 17, 2009. European consignees were sent recall notification on February 23, 2009. The Australian consignees and New Zealand consignees were the sent recall communication on February 25, 2009. Customers were instructed to contact Ormco Customer Care at (800) 854-1741 to receive an RMA number. The affected product should be returned to Ormco Corporation at the following address: Ormco Corporation, 1332 South Lone Hill Avenue, Glendora, CA 91740. Customers were instructed to label their return product "RECALLED PRODUCT Attention: Customer Returns". Customers were instructed to complete the enclosed Return Form and return it by fax to (909) 962-5605. For questions regarding this recall call 909-962-5600.

Device

Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,
  • Modèle / numéro de série
    Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand.
  • Description du dispositif
    Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, || Part Numbers: 454-1210, 454-0210. || The intended use of this device is a 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