Events

Recall of Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Tornier Pty Ltd.

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
    RC-2013-RN-01035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01035-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier has initiated recall of all lots of aequalis reversed ii and reversed fracture impactors (items number mwd021, mwd023, mwd024, mwd025). upon review of the event, tornier determined that a redesign of the instrumentation was warranted.This recall action was carried out prior to approval by the therapeutic goods administration.
  • Action
    In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.

Device

Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II an...
  • Model / Serial
    Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)Aequalis Reversed II Insert Impaction HandleItem Number: MWD021Aequalis Reversed II Insert Impactor TipItem Number: MWD023Hemiprosthesis Adaptor Impactor TipItem Number: MWD024Aequalis Reversed II Anatomic Head Impactor TipItem Number: MWD024ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd