Events

Recall of IMPLANT HOLDER FOR SYNFIX-LR

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
    63258
  • Event Risk Class
    II
  • Event Initiated Date
    2010-08-13
  • 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 medical device labelling recall related to the synthes synfix-lr system technique guide specifically regarding use of the synfix implant holder. the surgical technique presented in the guide has been revised and emphasizes the importance of ensuring that the synfix-lr implant holder is not cross threaded when attached to the synfix-lr implant. the revision also describes the use of holding forceps.

Device

IMPLANT HOLDER FOR SYNFIX-LR
  • Model / Serial
    Model Catalog: 03.802.039 (Lot serial: )
  • Product Description
    IMPLANT HOLDER FOR SYNFIX-LR - SYSTEM TECHNIQUE GUIDE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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