Events

Recall of SCORPIO T72 INSERT TIBIAL TRIALS

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
    44999
  • Event Risk Class
    II
  • Event Initiated Date
    2010-07-30
  • 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
    Stryker orthopaedics has become aware that there is the potential for the above mentioned product to be oversized by a maximum of .024"(0.6mm). it was determined that an oversized tibial insert trial may sit on the anterior edge of the tibial baseplate if used for secondary trialing in a procedure. if there is an inability to seat the insert trial and impaction is used to seat the trial fracture of the device may occur.

Device

SCORPIO T72 INSERT TIBIAL TRIALS
  • Model / Serial
    Model Catalog: T-72 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    SCORPIO T72 INSERT TIBIAL TRIALS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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