Events

Recall of PILOT DRILL STAINLESS STEEL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STRAUMANN CANADA LIMITED.

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
    16421
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-28
  • 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 investigation of a complaint has confirmed that the shaft diameter of a drill (article 044.215 lot lv457) is greater than the defined specification of 2.35 mm in the area of the laser marking on the shaft. further investigation has shown that additional articles and lots are impacted. testing with different handpieces demonstrates that the drills can be inserted however depending on the manufacturing tolerances of the handpiece that is used these drills may not fit. the drills are multiple use instruments and are delivered non-sterile. in accordance with ifu 701124 they must be unpacked disinfected cleaned and sterilized before use. additionally the ifu states that "before every use the device has to be carefully checked for proper function and damage." if the drills do not fit into the handpiece and there is not an alternative instrument available then the planned treatment will need to be re-scheduled.

Device

PILOT DRILL STAINLESS STEEL
  • Model / Serial
    Model Catalog: 044.210 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: MH027); Model Catalog: 044.210 (Lot serial: MH027); Model Catalog: 044.215 (Lot serial: LV463); Model Catalog: 044.214 (Lot serial: LV463); Model Catalog: 044.210 (Lot serial: LV463); Model Catalog: 044.215 (Lot serial: LV457); Model Catalog: 044.214 (Lot serial: LV457); Model Catalog: 044.210 (Lot serial: MJ330); Model Catalog: 044.214 (Lot serial: MJ330); Model Catalog: 044.215 (Lot serial: MJ330); Model Catalog: 044.255 (Lot serial: LV455); Model Catalog: 044.215 (Lot serial: MH027)
  • Product Description
    PILOT DRILL - STAINLESS STEEL;TWIST DRILL - STAINLESS STEEL
  • Manufacturer
    STRAUMANN CANADA LIMITED

Manufacturer

STRAUMANN CANADA LIMITED