Events

Recall of SWIVEL ADAPTER ASSEMBLY HEADREST (PLASTIC)

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

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
    23699
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-01
  • 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
    This recall is for the mizuho osi coupler assembly ii (model 5873) used to position patients during orthopedic trauma and spinal procedures. the correction recall activity is due to a change in the labelling and as a result an updated owner's manual will be distributed to customers. there is no need to return any product or to discontinue the use of the coupler ii. this notice is intended to further educate the users on certain aspects of the device to ensure awareness and provide an updated owner's manual. mizuho osi has revised the coupler ii's owner manual descriptions and diagrams on the use of the device expected life cleaning and maintenance instructions.

Device

SWIVEL ADAPTER ASSEMBLY HEADREST (PLASTIC)
  • Model / Serial
    Model Catalog: 5873 (Lot serial: )
  • Product Description
    SWIVEL ADAPTER ASSEMBLY HEADREST (PLASTIC)
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.