Events

Rappel de PREMISE

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 Kerr Corp.

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
    49506
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0242-2009
  • Date de mise en oeuvre de l'événement
    2008-09-05
  • Date de publication de l'événement
    2008-11-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73731
  • 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
    dental composite - Product Code EBF
  • Cause
    Material stiff: material in several lots of premise unidose appears to stiffen and become difficult to extrude over time.
  • Action
    Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement

Device

PREMISE
  • Modèle / numéro de série
    LOT NUMBER(S): 3001306, 3001307, and 3001308
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
  • Description du dispositif
    PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite
  • Manufacturer
    Kerr Corp

Manufacturer

Kerr Corp
  • Adresse du fabricant
    Kerr Corp, 1717 W Collins Ave, Orange CA 92867-5422
  • Source
    USFDA