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
    59964
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-01
  • 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
    Complaints have been received which describe the synfix lr implant holder breaking at the interface between the implant and holder. if an unretrieved device fragment remains threaded into the plate it will not be possible to properly attach the synfix aiming device to the implant (plate). proper attachment of the aiming device to teh plate is required for accurate insertion of the four synfix screws into the synfix implant (plate) and verebral bodies. if the tip holder should break the potential exists for an untretrieved device fragment (urdf) to be left in the synfix-lr implant.

Device

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

Manufacturer

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