Events

Recall of TITANIUM BUTTON PLATE

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
    120984
  • Event Risk Class
    II
  • Event Initiated Date
    2016-07-18
  • 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 depuy synthes button plate(s) were distributed with a package insert containing incorrect mr safety information that does not meet the current astm standard. in 2008 standard method astm f2503 standard practice for marking medical devices and other items for safety in the magnetic resonance environment was revised. the synthes button plate was labelled as mr safe per the astm standard metallic devices are no longer identified as mr safe.

Device

TITANIUM BUTTON PLATE

Manufacturer

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