Events

Recall of EQUINOXE REVERSE SHOULDER SYSTEM - TORQUE DEFINING SCREW KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EXACTECH CANADA.

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
    16466
  • Event Risk Class
    II
  • Event Initiated Date
    2016-11-18
  • 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
    When the torque defining screw is tightened to the torque required to disengage the screw head the screw head will disengage as expected but it may not be retained in the torque defining screwdriver. this may cause a delay in surgery of less than 1 minute due to the need to pick up the screw head that was not retained by the driver. surgeons should also be advised that there is a potential for the screw head to fall into the wound site.

Device

EQUINOXE REVERSE SHOULDER SYSTEM - TORQUE DEFINING SCREW KIT
  • Model / Serial
    Model Catalog: 320-20-00 (Lot serial: > 10 numbers contact mfg.)
  • Product Description
    EQUINOXE REVERSE SHOULDER FIXED ANGLE TORQUE DEFINING SCREW KIT
  • Manufacturer
    EXACTECH CANADA

Manufacturer

EXACTECH CANADA
  • Manufacturer Address
    CALEDONIA
  • Manufacturer Parent Company (2017)
    Exactech Inc.
  • Source
    HC