Events

Recall of Device Recall Ultimate Dams

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coltene Whaledent 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
    67640
  • Event Risk Class
    Class 2
  • Event Number
    Z-2151-2014
  • Event Initiated Date
    2013-12-11
  • Event Date Posted
    2014-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128642
  • 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
    Dam, rubber - Product Code EIE
  • Reason
    Colt¿ne/whaledent inc. received a complaint about the dental dams being the incorrect color. during an internal investigation, the firm found that latex dental dams had been packaged in non-latex packaging.
  • Action
    The firm issued a press release, called the distributor and sent a certified letter. The firm obtained the distributor's distribution list and sent recall notifications to all of these consignees.The firm included envelopes and return/reply cards, via response form mailed, certified mailing with return receipt.

Device

Device Recall Ultimate Dams
  • Model / Serial
    Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in Memphis, TN.
  • Product Description
    Latex Dental Dams labeled as Non-Latex Dental Dams
  • Manufacturer
    Coltene Whaledent Inc

Manufacturer

Coltene Whaledent Inc
  • Manufacturer Address
    Coltene Whaledent Inc, 235 Ascot Parkway, Cuyahoga Falls OH 44223
  • Manufacturer Parent Company (2017)
    Coltene Holding AG
  • Source
    USFDA