Events

Recall of Device Recall Correct VPS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sybron Dental Specialties.

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
    59959
  • Event Risk Class
    Class 3
  • Event Number
    Z-1146-2012
  • Event Initiated Date
    2010-11-04
  • Event Date Posted
    2012-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104082
  • 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
    Material, impression - Product Code ELW
  • Reason
    Pentron clinical is voluntarily recalling the following lot of mislabeled correct vps medium body tubes. it was discovered that the individual tubes inside the correct vps medium body tube boxes are missing the lot/expiration date sticker.
  • Action
    Pentron Clinical sent "Urgent Medical Device Recall" letters dated November 17, 2010 to consignees explaining the above mentioned public reason for recalls and asking them to determine if they have any of the affected products in their in stock. Product that is returned will be replaced at no charge. They also asked that they complete and fax back an enclosed recall return form. Questions can be directed to Customer Service at (800) 551-0283.

Device

Device Recall Correct VPS
  • Model / Serial
    Lot Number: 3510059
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.
  • Product Description
    Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • Manufacturer Address
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA