Events

Recall of Device Recall Stage1 Tissue Punch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Keystone Dental 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
    79615
  • Event Risk Class
    Class 2
  • Event Number
    Z-1443-2018
  • Event Initiated Date
    2018-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162775
  • 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
    Accessories, implant, dental, endosseous - Product Code NDP
  • Reason
    The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
  • Action
    An Urgent - Medical Device Recall letter, dated January 31, 2018, was sent to the impacted customers on 02/01/2018. The letter identified the affected device and the reason for the recall. Customers were instructed to immediately cease using the recalled product and return unused products to Keystone Dental. Customer Relations Reply Forms are being utilized to document the communication. Completed Relations Reply Forms should be faxed/ emailed to Customer Support; 866-903-9272 or customersupport@keystonedental.com.

Device

Device Recall Stage1 Tissue Punch
  • Model / Serial
    Lot numbers:  33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and  34987, expiration date: 2022-07.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
  • Product Description
    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. || Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
  • Manufacturer
    Keystone Dental Inc

Manufacturer

Keystone Dental Inc
  • Manufacturer Address
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • Manufacturer Parent Company (2017)
    Keystone Dental Inc
  • Source
    USFDA