Events

Rappel de Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve

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 Sybron Dental Specialties.

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
    70551
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1291-2015
  • Date de mise en oeuvre de l'événement
    2015-02-11
  • Date de publication de l'événement
    2015-03-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134019
  • 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
    Cover, barrier, protective - Product Code MMP
  • Cause
    Cases of cure sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. there is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
  • Action
    The firm sent out letters to customers on 02/11/15. The firm's letter states that they are willing to replace or credit back customers if they have any of the affected product, and instruct them to contact Metrex Research Customer Care at 1-800-841-1428 in order to receive an RMA number. The firm also requests that customer complete and fax back the enclosed reply form in order to confirm receipt of this advisory notification. The firm also states that if the customer is a distributor that they identify the customers that might have received the affected product, and contact them within 48 hours.

Device

Device Recall Pinnacle Cure Sleeve, Curing Light Tip Sleeve
  • Modèle / numéro de série
    Part Number: 4513C or 4513-1.  Lot Number: 2014030110
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,
  • Description du dispositif
    Outer cardboard box labeling: || Pinnacle Cure Sleeve, Curing Light Tip Sleeves. || Kerr Total Care. || Part Number: 4513C or 4513-1 || Single Patient Use || Fits 13mm Tips. Pack of 400. || Metrex Research, Manufacturer. || Inner individual packaging of each sleeve: || Cure Sleeve by Pinnacle || Model 4500
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Adresse du fabricant
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA