Events

Recall of STANDARD OFFSET CUP IMPACTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    137235
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-15
  • 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
    As a follow-up to a notice issued in august 2014 regarding the greatbatch medical mto offset cup impactor instruments depuy orthopaedics inc. is replacing the "blue handle" device (2999-60-834 and 2999-63-158) which requires non-traditional sterilization parameters with the greatbatch medical offset cup impactor with metal handle instrument (2550-00-115) which uses traditional sterilization parameters.

Device

STANDARD OFFSET CUP IMPACTOR

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.