Events

Recall of ORTHOPAEDIC WIRES

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
    75387
  • Event Risk Class
    III
  • Event Initiated Date
    2015-12-29
  • 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
    The wire packages are correctly marked with a 'non-sterile' label however the enclosed instructions for use (ifu) states the devices are sterilized via gamma irradiation and should not be re-sterilized. since the ifu states the devices are sterile no instructions for moist heat sterilization are provided. because the ifu does not provide information regarding sterilization the hospital staff may be confused.

Device

ORTHOPAEDIC WIRES
  • Model / Serial
    Model Catalog: 2704-3-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6703-1-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6704-1-018 (Lot serial: >10 lot numbers contact mfg); Model Catalog: 6704-3-120 (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    ORTHOPAEDIC WIRES
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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