Events

Rappel de Device Recall Brand Name: Vector TAS 8mm Screw.

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/Sybronendo.

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
    66173
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2194-2013
  • Date de mise en oeuvre de l'événement
    2013-07-12
  • Date de publication de l'événement
    2013-09-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121615
  • 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
    Implant, endosseous, orthodontic - Product Code OAT
  • Cause
    Ormco corporation is voluntarily recalling one lot of 8 mm vector tas screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Action
    Ormco sent an "Urgent Medical Device Recall letter dated July 12, 2013, via USPS 1st class mail, along with a return form to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were informed of the recall, with product description, product codes, ship dates, contact information and instructions to return any affected product identified in stock, Additionally, doctors are instructed to proceed with treatment if the screw has already been placed and to take special care not to over-torque the screw upon removal. Periodic effectiveness checks will be conducted in order to follow up with non-responders. Please fax this acknowledgement form to the the following number to confirm receipt of this notification whether or not you have any affected products. (714) 288-4603

Device

Device Recall Brand Name: Vector TAS 8mm Screw.
  • Modèle / numéro de série
    Lot Number 112911: 8 MM Vector TAS Screw, Part Number 601-0021 Lot Number 112911: Vector TAS Starter Kit (10 Patient), Part Number 601-0010
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Canada, Australia, New Zealand, EU and ROW consignees.
  • Description du dispositif
    Brand Name: Vector TAS 8mm Screw. || The Device Listing Number is E670535. || Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices.
  • Manufacturer
    Ormco/Sybronendo

Manufacturer

Ormco/Sybronendo
  • Adresse du fabricant
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA