Events

Recall of Device Recall OptraPol Polishing Discs

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ivoclar Vivadent, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74622
  • Event Risk Class
    Class 2
  • Event Number
    Z-2373-2016
  • Event Initiated Date
    2016-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148060
  • Notes / Alerts
    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.
  • Extra notes in the data
    Disk, abrasive - Product Code EHJ
  • Reason
    After a few seconds of polishing with moderate force, parts of the optrapol cup are breaking away. optrapol small flame is also affected. two complaints were filed referring to optrapol, claiming that the abrasive polishers wear faster than expected.
  • Action
    URGENT MEDICAL DEVICE RECALL Letter (dated 7/11/2016) and Response Form were sent to customers on 7/11/2016 via Certified Mail, Return Receipt, Requested. The letter instructs customers to notify their customers of the recall if the product had been distributed and to return the product to Ivoclar Vivadent. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.

Device

Device Recall OptraPol Polishing Discs
  • Model / Serial
    REF/Product ID 634459: Lot UL0843;  REF/Product ID 634458: Lot VL0704;  REF/Product ID 634464: Lot VL0705.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
  • Product Description
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.