Events

Recall of SYNEX II SYSTEM - CENTRAL BODY

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
    73277
  • Event Risk Class
    I
  • Event Initiated Date
    2009-09-23
  • 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. was notified by their supplier synthes (usa) of six complaints reported outside the us associated with synex ii implant (central body) which fully or partially collapsed in situ after a period of six to fifteen months post operatively.

Device

SYNEX II SYSTEM - CENTRAL BODY
  • Model / Serial
    Model Catalog: 04.808.003 (Lot serial: ALL LOTS); Model Catalog: 04.808.004 (Lot serial: ALL LOTS); Model Catalog: 04.808.011 (Lot serial: ALL LOTS); Model Catalog: 04.808.006 (Lot serial: ALL LOTS); Model Catalog: 04.808.001 (Lot serial: ALL LOTS); Model Catalog: 04.808.002 (Lot serial: ALL LOTS); Model Catalog: 04.808.005 (Lot serial: ALL LOTS); Model Catalog: 04.808.010 (Lot serial: ALL LOTS); Model Catalog: 04.808.009 (Lot serial: ALL LOTS); Model Catalog: 04.808.008 (Lot serial: ALL LOTS); Model Catalog: 04.808.007 (Lot serial: ALL LOTS)
  • Product Classification
    Orthopedic Devices
  • Product Description
    SYNEX II SYSTEM - CENTRAL BODY
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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