Events

Recall of Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes 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-2013-RN-00451-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00451-1
  • 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
    The hand piece' s outer hose can rupture without warning if the air flow is blocked during use, this issue involves all drill system hose assemblies manufactured prior to a design change that became effective on may 13, 2009 incorporating a pressure relief valve.
  • Action
    End users are requested to inspect their stock to determine if they have any pneumatic drill systems without a pressure release valve. All affected device are to be returned to DePuy Synthes for rework/modification.

Device

Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve ...
  • Model / Serial
    Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)ARTG Number: 141599
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd