Events

Recall of SHAVER HANDPIECE STERILIZATION TRAY

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

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
    25626
  • Event Risk Class
    III
  • Event Initiated Date
    2014-05-30
  • 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
    During testing shaver handpiece tray failed sterrad 100s half cycle testing and did not demonstrate a sterility assurance level of 10-6 for the tps shaver. it has been determined that the reprocessing guide (p10299 rev.A) is the non-conforming part of the shaver handpiece tray and the sterilization method with inadequate sterilization validation (sterrad 100s) needs to be removed as a sterilization option for the tps small joint shaver.

Device

SHAVER HANDPIECE STERILIZATION TRAY
  • Model / Serial
    Model Catalog: 0272-700-000 (Lot serial: >10 numbers contact mfg)
  • Product Description
    Shaver Handpiece Sterilization Tray
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC