Events

Recall of FLEXIBLE MEDULLARY REAMER

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
    110565
  • 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 affected flexible meduallary reamer. this recall is being initiated as the coiled design for this product is difficult to clean and the potential for corrosion on the device exists. the potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned. synthes has not received any reports of adverse events associated with the use of the flexible medullary reamer.

Device

FLEXIBLE MEDULLARY REAMER
  • Model / Serial
    Model Catalog: 359.115 (Lot serial: ALL LOTS); Model Catalog: 359.106 (Lot serial: ALL LOTS)
  • Product Description
    FLEXIBLE MEDULLARY REAMER
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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