Events

Recall of Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial Tray

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Exactech 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-2017-RN-01273-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01273-1
  • 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
    Exactech initiated a corrective action for the affected catalogue numbers due to a design incompatibility between the optetrak offset spine stiffener screw and the optetrak constrained condylar (cc) tibial insert when used in conjunction with an optetrak offset tibial tray. the optetrak offset spine stiffener screw is offered in a variety of sizes and is used as a secondary means to secure the optetrak constrained condylar (cc) tibial insert to the optetrak offset tibial tray. in all but one combination, the next size optetrak offset spine stiffener screw can be used without any anticipated adverse health consequences. exactech anticipates there may be a slight surgical delay while a larger screw is opened.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Exactech has provided users with an updated compatibility chart.

Device

Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when...
  • Model / Serial
    Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial TrayMultiple Catalogue Numbers and ProductsAll serial numbers affectedARTG Number: 252474
  • Manufacturer
    Exactech Australia Pty Ltd

Manufacturer

Exactech Australia Pty Ltd