Events

Recall of Device Recall Tytin Regular Set

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

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
    68426
  • Event Risk Class
    Class 2
  • Event Number
    Z-1788-2014
  • Event Initiated Date
    2014-05-29
  • Event Date Posted
    2014-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127565
  • 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
    Alloy, amalgam - Product Code EJJ
  • Reason
    Kerr corporation is recalling one (1) lot of tytin regular set ( part number 29948, lot number 3-1294), because it may set faster than specified in the directions for use.
  • Action
    Kerr Corporation initiated this recall by sending the recall notification letter accompanied by a return form, to customers via USPS 1st class mail. The consignees are instructed to complete the return form and return any affected product to Kerr Corporation. The recall notification letter, dated May 29, 2014, titled "URGENT: MEDICAL DEVICE RECALL", informed customers of the recall by providing the following information: product description with part number and lot number, distribution date range, reason for recall, risk statement, instructions to customers and/or Kerr distributor on what to do with the recalled product, FDA MEDWATCH reporting system info, and company contact information, and instructed customers to complete the return form titled "Acknowledgement and Recall Return Form".

Device

Device Recall Tytin Regular Set
  • Model / Serial
    Part Number 29948, Lot Number 3-1294. Expires October 2016
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
  • Product Description
    Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. || The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Manufacturer Address
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA