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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00200-1
Product Name/Description	HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis) Multiple Catalogue Numbers affected All unexpired lots ARTG Number: 173960
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/02/2014
Responsible Entity	Integra Neurosciences Pty Ltd
Reason/Issue	Integra Neurosciences has recently identified, through an internal evaluation, a risk of damage to the package (external pouch) of the Hintegra total ankle prosthesis tibial and talar components during shipping/handling. This damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. The risk for an adverse patient consequence has been determined to be not likely based on the manufacturer’s health hazard evaluation.
Recall Action	Recall for Product Correction
Recall Action Instructions	Integra trained representatives will be performing an inspection of the affected components at the healthcare facility before each surgery by following a verified inspection process. This will assure that only products without damages external pouches are used in surgeries.
Contact Information	1300 550 599 - Integra Customer Service