Events

Recall of Z DEPTH INDICATOR ANGULATED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by NOBEL BIOCARE CANADA 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
    16414
  • Event Risk Class
    II
  • Event Initiated Date
    2008-10-24
  • 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
    The z depth indicator angulated (dia 586) has incorrect depth indications. the first 30mm marking is correct however the following 4 markings have been manufactured with 4 mm distance instead of 5 mm.

Device

Z DEPTH INDICATOR ANGULATED
  • Model / Serial
    Model Catalog: PART OF KIT 29162 (Lot serial: 35517 (kit 29162)); Model Catalog: DIA 586 (Lot serial: 35517 (kit 29162)); Model Catalog: PART OF KIT 29162 (Lot serial: 33451); Model Catalog: DIA 586 (Lot serial: 33451); Model Catalog: PART OF KIT 27136 (Lot serial: 35517 (kit 29162)); Model Catalog: DIA 586 (Lot serial: 31085 (kit 27136)); Model Catalog: PART OF KIT 29162 (Lot serial: 31085 (kit 27136)); Model Catalog: PART OF KIT 27136 (Lot serial: 31085 (kit 27136)); Model Catalog: PART OF KIT 27136 (Lot serial: 33451)
  • Product Description
    Z DEPTH INDICATOR ANGULATED
  • Manufacturer
    NOBEL BIOCARE CANADA INC

Manufacturer

NOBEL BIOCARE CANADA INC