Events

Recall of 2.4MM LC-DCP PLATE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SYNTHES (CANADA) LTD..

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
    72354
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-27
  • 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
    Synthes (canada) ltd. is initiating a voluntary recall of the affected part number 249.926 lot number 8093100 for the synthes 2.4mm lc-dcp plate 6 holes 51mm. this recall is being initiated following synthes' receipt of a complaint regarding a screw being found in a package labeled for a 2.4 mm lc-dcp plate. the potential hazard of the presence of a screw in a package that should contain a plate does not pose the risk of harm to a patient. as the device is non-sterile and packaged in a clear bag the component will be easily recognizable as the incorrect part.

Device

2.4MM LC-DCP PLATE
  • Model / Serial
    Model Catalog: 249.926 (Lot serial: 8093100)
  • Product Description
    2.4MM LC-DCP PLATE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

SYNTHES (CANADA) LTD.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    HC