Events

Recall of Device Recall Keystone Dental PrimaConnex Straight 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
    76782
  • Event Risk Class
    Class 2
  • Event Number
    Z-1818-2017
  • Event Initiated Date
    2017-03-09
  • Event Date Posted
    2017-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154175
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Reason
    Straight primaconnex implants contained tapered primaconnex implants.
  • Action
    Keystone Dental initiated a market removal communication by telephone to customers on 3/9/2017. Customer Relations Fax Back Forms were completed to document these calls. In addition, a letter was sent via Federal Express/or hand delivered to all distributors and customers on 3/13/2017. Product returns requested and if implanted to implement healing and prosthetic protocol. Toll Free: 866-902-9272

Device

Device Recall Keystone Dental PrimaConnex Straight Implant TC
  • Model / Serial
    Lot Number: 30214
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA, IL, IN, FL, MA, MN, NJ, NV, PA,
  • Product Description
    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. || Catalog Number(s): 15636K
  • 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