Events

Recall of STERIS FINE TRACTION DEVICE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by STERIS CANADA INCORPORATED.

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
    96428
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-04
  • 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 fine traction device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. it is an accessory to the ot1000 series orthopedic surgical tables. steris has learned that the fine traction hand crank and rotation unlock button may lock up causing the fine traction adjustment of this accessory to be inoperable. steris has received no reports of illness or injuries one delay prior to the start of a procedure requiring the patient to be transferred to another surgical table to perform the procedure.

Device

STERIS FINE TRACTION DEVICE
  • Model / Serial
    Model Catalog: 10009177 (Lot serial: S/N: 0409813100); Model Catalog: 10009177 (Lot serial: S/N: 0409813097)
  • Product Description
    STERIS FINE TRACTION DEVICE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC