Events

Recall of OASYS SYSTEM - MIDLINE OCCIPUT PLATE

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
    20232
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-26
  • 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 has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

Device

OASYS SYSTEM - MIDLINE OCCIPUT PLATE
  • Model / Serial
    Model Catalog: 48571045 (Lot serial: LARGE LONG); Model Catalog: 48571044 (Lot serial: LARGE LONG); Model Catalog: 48571048 (Lot serial: LARGE); Model Catalog: 48571047 (Lot serial: LARGE); Model Catalog: 48571046 (Lot serial: LARGE); Model Catalog: 48571045 (Lot serial: LARGE); Model Catalog: 48571045 (Lot serial: MINI); Model Catalog: 48571048 (Lot serial: MEDIUM); Model Catalog: 48571047 (Lot serial: MEDIUM); Model Catalog: 48571046 (Lot serial: MEDIUM); Model Catalog: 48571045 (Lot serial: MEDIUM); Model Catalog: 48571044 (Lot serial: MEDIUM); Model Catalog: 48571048 (Lot serial: SMALL); Model Catalog: 48571047 (Lot serial: SMALL); Model Catalog: 48571046 (Lot serial: SMALL); Model Catalog: 48571045 (Lot serial: SMALL); Model Catalog: 48571044 (Lot serial: SMALL); Model Catalog: 48571048 (Lot serial: MINI); Model Catalog: 48571047 (Lot serial: MINI); Model Catalog: 48571046 (Lot serial: MINI); Model Catalog: 48571046 (Lot serial: LARGE LONG); Model Catalog: 48571047 (Lot serial: LARGE LONG); Model Catalo
  • Product Description
    OASYS Midline Occiput Plates
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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