Events

Recall of 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
    75224
  • Event Risk Class
    Class 2
  • Event Number
    Z-0299-2017
  • Event Initiated Date
    2016-09-15
  • Event Date Posted
    2016-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149695
  • 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
    Small diameter (sd) cover screw was packaged with the regular diameter implant and do not match the implant diameter (rd).
  • Action
    Keystone Dental initially called all customers on September 15, 2016. Forms were completed to document these calls. In addition a letter has been sent via Federal Express/or hand delivered on September 19, 2016, to all distributors and customers. Customers with questions were instructed to contact Customer Relations. For questions regarding this recall call 781-328-3390.

Device

Keystone Dental PrimaConnex Straight Implant TC
  • Model / Serial
    Lot # 27714
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
  • Product Description
    Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. || Product code:15613K || Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
  • 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