Events

Recall of RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES

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
    78445
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-03
  • 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
    The third party supplier for material used to manufacture the restoration modular components has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. as a precaution and due to the potential impact on the mechanical properties of the affected products stryker is recalling all products manufactured from material supplied by this supplier.

Device

RESTORATION MODULAR HIP SYSTEM - MODULAR CALCAR BODIES
  • Model / Serial
    Model Catalog: 6276-4-131 (Lot serial: T80551AA); Model Catalog: 6276-4-221 (Lot serial: T80998AC); Model Catalog: 6276-4-225 (Lot serial: T80551AA); Model Catalog: 6276-4-119 (Lot serial: T80554AA); Model Catalog: 6276-4-123 (Lot serial: T80554AA); Model Catalog: 6276-4-127 (Lot serial: T80554AA); Model Catalog: 6276-4-131 (Lot serial: T80554AA); Model Catalog: 6276-4-221 (Lot serial: T80554AA); Model Catalog: 6276-4-225 (Lot serial: T80554AA); Model Catalog: 6276-4-119 (Lot serial: T80998AA); Model Catalog: 6276-4-123 (Lot serial: T80998AA); Model Catalog: 6276-4-127 (Lot serial: T80998AA); Model Catalog: 6276-4-131 (Lot serial: T80998AA); Model Catalog: 6276-4-221 (Lot serial: T80998AA); Model Catalog: 6276-4-225 (Lot serial: T80998AA); Model Catalog: 6276-4-119 (Lot serial: T80998AC); Model Catalog: 6276-4-123 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80998AC); Model Catalog: 6276-4-131 (Lot serial: T80998AC); Model Catalog: 6276-4-127 (Lot serial: T80551AA); Model Catalog: 6276-4-1
  • Product Description
    RESTORATION MODULAR CALCAR BODIES
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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