Events

Recall of Mako THA Application User Guides

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-01129-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01129-1
  • 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
    Stryker has identified that the tha application user guides for specific item numbers did not have the risk control measure included. five risk control measure were not included in the specific tha application user guides:1. user guide warning to indicate risk of greater trochanter fracture due to insertion of screw.2. user manual instruct no to re-capture check-point without re-registration of bone.3. statement in the user guide to unscrew the impaction handle from the implant cup prior to freeing the rio arm.4. training and user guide will indicate insertion of femoral checkpoint may weaken great trochanter. 5. end effector (item number 205020) provides sufficient clearance to mitigate the risk of impingement. standard or technique to visually confirm that cuposition is correct.
  • Action
    1. Inform users of this Recall for Product Correction and forward this notice to all those individuals who need to be aware within your organisation; 2. A Stryker representative will coordinate the swap out of the old version of the User Guides with the new version. The old version may continue to be used until the swap out has occurred; 3. Complete the supplied “Recall for Product Correction Notification Response” form upon receiving the letter to acknowledge you have seen it; and 4. Inform any recipients you may have transferred affected stock to.

Device

Mako THA Application User Guides
  • Model / Serial
    Mako THA Application User GuidesItem Numbers: 204863, 207116, 208692, 209711, 210555 and 212026All lots and versionsARTG Number: 223106
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA