Events

Rappel de Device Recall Nakanishi Inc.

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 Nakanishi 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
    74666
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2674-2016
  • Date de mise en oeuvre de l'événement
    2016-07-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148155
  • 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
    Handpiece, air-powered, dental - Product Code EFB
  • Cause
    Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. a contributing factor to this error is that in other markets such as japan, the diamond coated tips are multiple use and are not limited to single use only. the tips are stainless steel with a coating of fine diamond powder. the tips are sold non-sterile and are to be sterilized prior to first use. the tips were cleared as single use only. this problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by nakanishi in october 2014. because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. the absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
  • Action
    Naknishi sent out an URGENT : MEDICAL DEVICE CORRECTION letter on July 18, 2016 describing the potential safety issue regarding their Diamond Coated Products. The firm is requesting customers take the following actions: 1. Examine their inventory immediately to determine if they have any product, both used and unused, bearing any of the Nakanishi Product Codes listed in List of Products enclosed with this letter. 2. Immediately dispose of any USED product according to applicable regulations. 3. Segregate any UNUSED product for return to Nakanishi. 4. In order for the firm to complete their records, they are requesting that customers complete the enclosed Correction Activity Sheet and FAX or Mail to: NSK America, Corp. 1800 Global Parkway, Hoffman Estates, IL 60192 US Facsimile: 1-800-838-9328 Customers with questions were advised to Telephone: 1-888-675-1675. NSKrecall@NSKDental.com For questions regarding this recall call 847-843-7664.

Device

Device Recall Nakanishi Inc.
  • Modèle / numéro de série
    Waiting for clarification from the firm.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to Illinois, Florida and Georgia.
  • Description du dispositif
    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) || The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
  • Manufacturer
    Nakanishi Inc.

Manufacturer

Nakanishi Inc.
  • Adresse du fabricant
    Nakanishi Inc., 700, Shimohinata, Kanuma Japan
  • Société-mère du fabricant (2017)
    Nakanishi Inc.
  • Source
    USFDA