Events

Recall of TRIATHLON TOTAL KNEE SYSTEM - TS FEMORAL COMPONENTS

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
    93592
  • Event Risk Class
    II
  • Event Initiated Date
    2017-06-29
  • 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
    It was discovered during manufacturing that size 3 and 4 triathlon cemented revision femoral components had excess metal trapped in the size and lot code marking imprints. analysis showed that the material trapped in the imprint was 304 stainless steel blast media which is used to grit blast the implants during the manufacturing process.

Device

TRIATHLON TOTAL KNEE SYSTEM - TS FEMORAL COMPONENTS
  • Model / Serial
    Model Catalog: 5512-F-301 (Lot serial: AGD9R)
  • Product Description
    TRIATHLON TOTAL KNEE SYSTEM - TS FEMORAL COMPONENT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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