Events

Recall of Alpen Carbide 702 Cross Cut Tapered Fissure

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
    79994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1883-2018
  • Event Initiated Date
    2018-04-13
  • Event Date Posted
    2018-05-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164149
  • 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
    Bur, dental - Product Code EJL
  • Reason
    The products are labeled with an incorrect product number.
  • Action
    Customers were contacted via telephone call on 4/13/18. The customers were asked the following questions: 1. Confirm that {name of Distributor} received {number of packs} around this date {date}. 2. Confirm that the affected product, lot number I37460, is still in their inventory. a. If not, to whom was it shipped to? [Coltene will need that contact information]. 3. Can you take a picture of the lot number I37460 that you received and send to {Regional sales manager}? 4. Please return the product in question to Coltene per Vendor Return Authorization with full tracking information.

Device

Alpen Carbide 702 Cross Cut Tapered Fissure
  • Model / Serial
    Batch I37640
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
  • Product Description
    Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
  • Manufacturer
    Coltene Whaledent Inc

Manufacturer

Coltene Whaledent Inc
  • Manufacturer Address
    Coltene Whaledent Inc, 235 Ascot Pkwy, Cuyahoga Falls OH 44223-3701
  • Manufacturer Parent Company (2017)
    Coltene Holding AG
  • Source
    USFDA