Events

Recall of HACTIV Calcar reamers

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude Australia 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-2018-RN-00156-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-03-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00156-1
  • 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
    Amplitude australia has been notified by the manufacturer, evolutis, that certain batches of the calcar reamer show a defect in the sharpening of the teeth.
  • Action
    Amplitude is advising that unaffected reamers are expected to be available 15th March 2018. Amplitude will arrange exchange of affected units from users.

Device

HACTIV Calcar reamers
  • Model / Serial
    HACTIV Calcar reamersPart Numbers: H01 058 - Calcar reamer 40 Harris connect - HyperionBatch Numbers: P1605804, P17061051Part Numbers: H01 060 - Calcar reamer 48 Harris connect - Hyperion Batch Numbers: P16051337, P1605805ARTG Number: 157418(Amplitude Australia - Prosthetic joint implantation kit)
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd