Events

Recall of XIVE S SCREW IMPLANT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DENTSPLY INTERNATIONAL INC. DENTSPLY TULSA DENTAL SPECIALTIES.

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
    39286
  • Event Risk Class
    III
  • Event Initiated Date
    2006-11-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Bronze caps on vials containing xive 3.0 dental implants cracked along bottom circumference of caps. recall does not affect already inserted product. affected lot codes have last four digits less than 1595.

Device

XIVE S SCREW IMPLANT
  • Model / Serial
    Model Catalog: 26-0123 (Lot serial: all w/ last 4 digits < 1595); Model Catalog: 26-0125 (Lot serial: all w/ last 4 digits < 1595); Model Catalog: 26-0122 (Lot serial: all w/ last 4 digits < 1595)
  • Product Description
    XiVE 3.0 Dental Implant System
  • Manufacturer
    DENTSPLY INTERNATIONAL INC. DENTSPLY TULSA DENTAL SPECIALTIES

Manufacturer

DENTSPLY INTERNATIONAL INC. DENTSPLY TULSA DENTAL SPECIALTIES