Events

Recall of Device Recall RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS

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
    79110
  • Event Risk Class
    Class 2
  • Event Number
    Z-0727-2018
  • Event Initiated Date
    2017-08-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161389
  • 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
    The recalled units are mislabeled with an incorrect expiration date. the expiration date printed on the label is 2202-06. the correct expiration date should be 2022-06.
  • Action
    On August 18, 2017 a letter titled "Product Action  S2400K, Stage-1 RDS Indexed Abutment, Lot 34276" was issued to customers requesting persons to review their inventory and respond if product has been used or not. A response form is requested from these customers with instruction to return any unused product. Questions or concerns can be directed to: Customer Relations: Toll Free 866-902-9272

Device

Device Recall RESTORE, STAGE1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
  • Model / Serial
    Catalog# S2400K, Lot 34276
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationally.
  • Product Description
    Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage || Implants || Keystone s implants are intended for 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