Events

Recall of Device Recall PrimaConnex Implant System

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
    79040
  • Event Risk Class
    Class 2
  • Event Number
    Z-0608-2018
  • Event Initiated Date
    2017-06-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161223
  • 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
    Abutment, implant, dental, endosseous - Product Code NHA
  • Reason
    Abutments are unable to accept the final abutment screw.
  • Action
    On June 20, 2017 Keystone Dental telephoned impacted customers and advised them of the problem. On July 3rd, 2017 Keystone Dental issued notices (dated June 29, 2017) and response forms to customers via Fed Ex. Customers were encouraged to complete and return the response form attached form to confirm receipt of the replacement product and that lot 33006 can be returned to Keystone Dental. Customers with questions can call Johanna Drzyzga, Customer Relations Manager at 866-902-9272.

Device

Device Recall PrimaConnex Implant System
  • Model / Serial
    REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of ND, NJ & MA
  • Product Description
    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K || pRODUCT Usage: || Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate 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