Events

Recall of REFLEX-HYBRID SCREW EXTRACTOR

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
    26661
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-21
  • 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 reflex hybrid screw extractor inner shaft was reported to fail at the threaded tip and fracture in the head of the screw. there had been reports of the threaded tip of the inner shaft being left in the screw due to the surgeon being unable to remove the screw. there had also benn reports of damage to the screw and/or the plate while attempting to remove the screw.

Device

REFLEX-HYBRID SCREW EXTRACTOR
  • Model / Serial
    Model Catalog: 48511905D (Lot serial: ALL); Model Catalog: 48511905B (Lot serial: ALL)
  • Product Description
    REFLEX HYBRID SCREW EXTRACTOR INN.SHAFT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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