Events

Recall of DISTAL RADIUS PLATE SYSTEM - LOCKING SCREW SELF TAPPING W/STARDRIVE

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
    35094
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-19
  • 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
    It was discovered that part number(212.818) and lot 7856527 of 2.4mm locking screws may contain the incorrect package insert (gp2613 va-lcp distal radius system). the correct package insert for the above part is gp2615 (modular mini fragment lcp system).

Device

DISTAL RADIUS PLATE SYSTEM - LOCKING SCREW SELF TAPPING W/STARDRIVE

Manufacturer

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