Events

Recall of SYNFIX-LR SYSTEM - IMPLANT

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
    151371
  • Event Risk Class
    II
  • Event Initiated Date
    2012-10-17
  • 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
    The indications on the current version of the synfix lr system package insert differ from the indications approved by health canada on licence #77494. the package insert contains labelling that indicates it is approved for vertebral body replacement (vbr). this is not an approved indication for use in canada. the approved indications for use in canada are for interbody fusion (ibf).

Device

SYNFIX-LR SYSTEM - IMPLANT
  • Model / Serial
    Model Catalog: 08.802.019S (Lot serial: ALL LOTS); Model Catalog: 08.802.016S (Lot serial: ALL LOTS); Model Catalog: 08.802.015S (Lot serial: ALL LOTS); Model Catalog: 08.802.014S (Lot serial: ALL LOTS); Model Catalog: 08.802.013S (Lot serial: ALL LOTS); Model Catalog: 08.802.012S (Lot serial: ALL LOTS); Model Catalog: 08.802.011S (Lot serial: ALL LOTS); Model Catalog: 08.802.010S (Lot serial: ALL LOTS); Model Catalog: 08.802.009S (Lot serial: ALL LOTS); Model Catalog: 08.802.008S (Lot serial: ALL LOTS); Model Catalog: 08.802.007S (Lot serial: ALL LOTS); Model Catalog: 08.802.006S (Lot serial: ALL LOTS); Model Catalog: 08.802.005S (Lot serial: ALL LOTS); Model Catalog: 08.802.004S (Lot serial: ALL LOTS); Model Catalog: 08.802.003S (Lot serial: ALL LOTS); Model Catalog: 08.802.002S (Lot serial: ALL LOTS); Model Catalog: 08.802.000S (Lot serial: ALL LOTS); Model Catalog: 08.802.001S (Lot serial: ALL LOTS); Model Catalog: 08.802.018S (Lot serial: ALL LOTS); Model Catalog: 08.802.017S (Lot serial: ALL LOTS); Mod
  • Product Description
    SYNFIX-LR SYSTEM - IMPLANT
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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