Events

Recall of ADVANCED CEMENT MIXING BOWL EMPTY CEMENT CARTRIDGE NOZZLE AND PRESSURIZER

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
    137001
  • Event Risk Class
    I
  • Event Initiated Date
    2017-11-22
  • 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 routine bioburden testing [november 10th to 20th 2017] stryker found that the levels of bioburden were higher than our internal acceptable rates. therefore stryker is initiating this voluntary recall as the sterility of the product cannot be confirmed.

Device

ADVANCED CEMENT MIXING BOWL EMPTY CEMENT CARTRIDGE NOZZLE AND PRESSURIZER
  • Model / Serial
    Model Catalog: 0306-573-000 (Lot serial: 17283012); Model Catalog: 0605-887-000 (Lot serial: 17278012); Model Catalog: 0206-546-000 (Lot serial: 17276012); Model Catalog: 6198-001-514 (Lot serial: 17284012)
  • Product Classification
    Orthopedic Devices
  • Product Description
    ADVANCED CEMENT MIXING BOWL EMPTY CEMENT CARTRIDGE NOZZLE AND PRESSURIZER;STRYKER AUTOPLEX SYSTEM WITHOUT NEEDLES AND CEMENT;PROX PRESS;INTRAMEDULLARY BRUSHES - DISPOSABLE
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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