Events

Recall of Device Recall Keystone PrimaConnex Tapered Implant TC

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
    64633
  • Event Risk Class
    Class 2
  • Event Number
    Z-0973-2013
  • Event Initiated Date
    2013-03-11
  • Event Date Posted
    2013-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116685
  • 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
    Mislabeled: cover screw that was in the package was a wd cover screw and not a sd cover screw as labeled.
  • Action
    Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.

Device

Device Recall Keystone PrimaConnex Tapered Implant TC
  • Model / Serial
    Lot Number: 12857
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
  • Product Description
    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm || Catalog Number: l5613K. || Implants in support for fixed bridgework.
  • Manufacturer
    Keystone Dental Inc

Manufacturer

Keystone Dental Inc
  • Manufacturer Address
    Keystone Dental Inc, 144 Middlesex Tpke, Burlington MA 01803-4403
  • Manufacturer Parent Company (2017)
    Keystone Dental Inc.
  • Source
    USFDA