Events

Recall of LOCKING CONDYLAR PLATING (LCP) SYSTEM - CURVED CONDYLAR 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
    107133
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-12
  • 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 to remove the 4.5mm curved condylar plate. this recall is being initiated as the straight condylar plate is etched with a curved condylar plate part number. the potential hazard is a possibility of a delayed surgical procedure. synthes has not received any reports of adverse events associated with the use of the 4.5mm lcp curved condylar plate subject to this notice.

Device

LOCKING CONDYLAR PLATING (LCP) SYSTEM - CURVED CONDYLAR PLATE
  • Model / Serial
    Model Catalog: 02.001.324 (Lot serial: 6900823)
  • Product Description
    4.5mm LCP Curved Condylar Plate
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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