Events

Recall of MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION WITHOUT BODY

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
    129214
  • Event Risk Class
    II
  • Event Initiated Date
    2009-03-05
  • 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
    There are no warnings on the label or ifu that the 8 9 10mm diameter mrs cemented heads should only be used with the gmrs distal femoral components and the gmrs proximal tibial components.

Device

MODULAR REPLACEMENT SYSTEM - FEMORAL STEM SECTION WITHOUT BODY
  • Model / Serial
    Model Catalog: 6485-3-018 (Lot serial: TEC077); Model Catalog: 6485-3-010 (Lot serial: TEC077); Model Catalog: 6485-3-019 (Lot serial: TEC231A); Model Catalog: 6485-3-018 (Lot serial: TEC231A); Model Catalog: 6485-3-019 (Lot serial: TEC077); Model Catalog: 6485-3-010 (Lot serial: TEC231A); Model Catalog: 6485-3-018 (Lot serial: TEC078B); Model Catalog: 6485-3-019 (Lot serial: TEC078B); Model Catalog: 6485-3-010 (Lot serial: TEC078B)
  • Product Description
    MRS CEMENTED STEMS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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