Events

Recall of REAMING ROD (MEDULLARY NAILS)

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
    18858
  • Event Risk Class
    II
  • 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
    In some sterile packages the sterility may be compromised.

Device

REAMING ROD (MEDULLARY NAILS)
  • Model / Serial
    Model Catalog: (Lot serial: XVC2608 and XVC2609); Model Catalog: (Lot serial: A3JQ545 A3JV989 A3JQ546); Model Catalog: (Lot serial: A3JT680 A3JK922 A3II682); Model Catalog: (Lot serial: A3JS141 A3IQ839 A3IQ842); Model Catalog: (Lot serial: A3IO738 A3IP115 A3JQ213)
  • Product Description
    SYNTHES REAMING RODS AND MEDULLARY TUBE
  • Manufacturer
    SYNTHES (CANADA) LTD.

Manufacturer

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