Events

Recall of MHD-97B BORING TOOL

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
    37496
  • Event Risk Class
    II
  • Event Initiated Date
    2008-08-15
  • 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 face of the cutter was machined incorrectly resulting in a concave (curved inward) cutter face rather than convex as designed.

Device

MHD-97B BORING TOOL
  • Model / Serial
    Model Catalog: MHD-97B (Lot serial: B163006631); Model Catalog: MHD-98B (Lot serial: B093004858); Model Catalog: MHD-98B (Lot serial: b093004926)
  • Product Description
    12.6mm Boring Tool
  • Manufacturer
    THE ANSPACH EFFORT INC.

Manufacturer

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