Events

Safety Alert for Aequalis Reversed II and Reversed Fracture impactors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Tornier SAS.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-14
  • Event Date Posted
    2013-08-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130814.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: tornier aequalis reversed ii and reversed fracture impactors medical device manufacturer, tornier sas issued a medical device safety alert concerning all lots of aequalis reversed ii and reversed fracture impactors. the affected item numbers are mwd021, mwd023, mwd024, mwd025. following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier reviewed the event and determined that a redesign of the instrumentation was warranted. the manufacturer initiated a voluntary recall of the product. the recalled instruments will be replaced by a new design in the near future. in the interim, tornier recommends assembling the humeral components and glenoid sphere according to the surgical technical addendum attached with their field safety notice. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 august 2013.

Device

Aequalis Reversed II and Reversed Fracture impactors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Tornier Aequalis Reversed II and Reversed Fracture impactors
  • Manufacturer
    Tornier SAS

Manufacturer

Tornier SAS