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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01207-1
Product Name/Description	Titanium Fluted Stem Extender (used with Stryker’s Duracon and Scorpio Total Stabiliser Knee Implant Systems and Modular Rotating Hinge (MRH) Knee Implant Systems) Multiple Item Numbers and Lot Numbers affected ARTG Number: 242297
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	8/12/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has become aware of the potential for confusion with regards to the intended use for the Titanium Fluted Stem Extender, based on the addition of the text "Cemented Use Only" on the product label. The fixation method of the Titanium Fluted Stem Extenders is not restricted in Australia, and can be used for Cemented or Cementless applications, even though the labelling states "Cemented Use Only". As a result, there exists the potential for confusion in the operating theatre, resulting in complications associated with a surgery time of less than five minutes.
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately check all stock areas and quarantine any affected item. A Stryker Representative will contact customers to arrange for all affected components to be removed from the facility and arrange for a replacement, as required.
Contact Information	02 9467 1052 - Stryker