Events

Recall of ATTUNE DISTAL FEMORAL JIG

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
    18401
  • Event Risk Class
    II
  • Event Initiated Date
    2014-10-22
  • 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
    Depuy is issuing a device correction notice for all lots because if the metal pin bushing is overloaded there is the potential for partial or full displacement of the metal pin bushing along with fracture of the plastic around it resulting in the potential for fragments of the fractured plastic to be left in the patient. depuy is also conducting an inspection and swap-out of specific lots (in canada lot abc4112) because the instruments may be assembled incorrectly.

Device

ATTUNE DISTAL FEMORAL JIG

Manufacturer

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