Events

Recall of BURR - DIAMOND BALL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by THE ANSPACH EFFORT 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
    56561
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-09
  • 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
    Retrospective report for voluntary correction of anspach 3mm diamond ball cutting burr (2011/03/04). three batches of the product may have diamond grit size larger than intended applied to the head of the cutting burr resulting in a possibly more agressive cutting burr.

Device

BURR - DIAMOND BALL
  • Model / Serial
    Model Catalog: S-3D (Lot serial: D433040800); Model Catalog: S-3D (Lot serial: D403040236); Model Catalog: S-3D (Lot serial: D383039472)
  • Product Description
    3mm Diamond Ball Extended Length Cutting Bur
  • Manufacturer
    THE ANSPACH EFFORT INC.

Manufacturer

THE ANSPACH EFFORT INC.
  • Manufacturer Address
    PALM BEACH GARDENS
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC