Events

Rappel de DISPOSASHIELD

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 O'Ryan Industries Inc.

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
    61675
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1505-2012
  • Date de mise en oeuvre de l'événement
    2012-04-23
  • Date de publication de l'événement
    2012-05-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108697
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • Cause
    Disposa-shield disposable curing shield is recalled due to lacking 510k, pma or ide, and inadequate quality system.
  • Action
    The firm, O'Ryan Industries Inc., began to contact consignees by telephone and sent email on April 25, 2012. O'Ryan sent a recall notification letter dated May 7, 2012 to their customers through the Purchasing Agents and Order Department Personnel. The letter described the product, problem, and actions to be taken by the customers. Customers were advised to return the Disposa-Shield back to O'Ryan Industries. Customers can call O'Ryan Industries at 800-426-4311 or fax to 360-892-6742.

Device

DISPOSASHIELD
  • Modèle / numéro de série
    No serial numbers, no codes, and no expiration dates.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of NC, MN, OR and WI.
  • Description du dispositif
    DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. || The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. || There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. || The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. || The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. || The product is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***info@oryanindustries.com***'. || The private label is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
  • Manufacturer
    O'Ryan Industries Inc

Manufacturer

O'Ryan Industries Inc
  • Adresse du fabricant
    O'Ryan Industries Inc, 12711 NE 95th St, Vancouver WA 98682-2412
  • Société-mère du fabricant (2017)
    O'Ryan Industries Inc
  • Source
    USFDA