Events

Recall of Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer flex Gen.1- 3.14.251 Reaming shaft flex. Gen.1- 3.15.252 Countersink reamer flex. Gen.2- 3.14.256 Reaming shaft flex. 46-52 Gen.2- 3.14.257 Reaming shaft flex. 54-64 Gen.2- 3.14.258 Reaming shaft flex. 60-68 Gen.2- 3.14.259 Shaft flex. Gen.1- 3.40.501 Countersink reamer flex. Gen.3- 55.02.1901 Reaming shaft flex. Gen.3- 55.02.1903 seleXys Shaft flex- 5502.00.2 Shaft flex- 3.14.545

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mathys Orthopaedics 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-2014-RN-00794-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00794-1
  • 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 validated process for the flexible shaft provides directions for a combined manual and mechanical cleaning/disinfection procedure. if the mandatory manual process as described in the processing instruction cannot be ensured/ performed, instruments by mathys ltd with flexible shafts may not be used. mathys ltd received feedback from hospitals that although the guidelines for processing and sterilising instruments were followed, residues on the instrument were still found. therefore mathys has developed an update to the processing instructions for the concerned instruments.
  • Action
    Mathys is notifying end users of the validated method for cleaning/disinfection of flexible shafts.

Device

Surgical Instruments with flexible shafts Description & Article RM Classic Countersink reamer fl...
  • Model / Serial
    Surgical Instruments with flexible shaftsDescription & ArticleRM Classic Countersink reamer flex Gen.1- 3.14.251Reaming shaft flex. Gen.1- 3.15.252Countersink reamer flex. Gen.2- 3.14.256Reaming shaft flex. 46-52 Gen.2- 3.14.257Reaming shaft flex. 54-64 Gen.2- 3.14.258Reaming shaft flex. 60-68 Gen.2- 3.14.259Shaft flex. Gen.1- 3.40.501Countersink reamer flex. Gen.3- 55.02.1901Reaming shaft flex. Gen.3- 55.02.1903seleXys Shaft flex- 5502.00.2Shaft flex- 3.14.545
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd