Events

Recall of Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is designed for treating shoulder conditions)

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-01305-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01305-1
  • 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 manufacturer, mathys ltd bettlach, received reports of disconnection of affinis inverse inlay ceramys and affinis fracture ceramic heads. subsequent investigations have identified that the inlay and individual implant components complied with the defined specifications.For affinis fracture ceramic heads:the disconnections may have resulted from inadequate primary fixation due to insufficient head-cone connection or by protruding bone residue, cement residue or soft tissue fragments inside the cone connection.For affinis inverse inlay ceramys: the disconnection incident was caused by insufficient fixation of the inlay on the cone due to lack of impaction. the affinis inverse inlay ceramys has not been supplied in australia.To minimise occurrences of disconnection, additional instructions and notes regarding ceramic inlay implantation and ceramic head implantation have been added to the surgical technique and the instructions for use (ifu).
  • Action
    Mathys Ltd Bettlach is requesting the customers to replace all Surgical Techniques and Instructions for Use (IFUs) for Affinis Inverse and/or Affinis Fracture with the updated versions provided. The sponsor has directly contacted the surgeon to notify of the implications of inadequate fixation and to provide the updated instructions. Further information will be published on the TGA web site at http://www.tga.gov.au/current-year-alerts This action has been closed-out on 14/07/2016.

Device

Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is des...
  • Model / Serial
    Affinis Inverse inlay ceramys & Affinis Fracture ceramic heads (Total Shoulder System that is designed for treating shoulder conditions)Affinis Inverse inlay ceramysItem numbers: 62.34.0066, 62.34.0067, 62.34.0068, 62.34.0069, 62.34.0070 62.34.0071, 62.34.0072, 62.34.0073 & 62.34.0074 Affinis Fracture ceramic headsItem numbers: 60.25.0042, 60.25.0045 & 60.25.0048 All Batch numbersARTG number: 215501
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd