Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00971-1
Product Name/Description	Duracon Augments - Tibial Wedge Implants Catalogue Numbers: 6630-6-105, 6630-6-110, 6630-6-125, 6630-6-130, 6630-6-150, 6630-6-155, 6630-6-170, 6630-6-175, 6630-6-205, 6630-6-210, 6630-6-225, 6630-6-230, 6630-6-250, 6630-6-255, 6630-6-270, 6630-6-275, 6630-6-305, 6630-6-310, 6630-6-325, 6630-6-330, 6630-6-350, 6630-6-355, 6630-6-370, 6630-6-375, 6630-6-405, 6630-6-410, 6630-6-425, 6630-6-430, 6630-6-450, 6630-6-455, 6630-6-470, 6630-6-475. Affected Lots: Multiple ARTG Number: 242298
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	2/10/2015
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	Stryker has received two customer complaints regarding Duracon Tibial Wedge implants that had punctured the packaging’s Tyvek lid. In each case, the punctured Tyvek lid was identified in the operating room and a new device was opened and used. In all Stryker Instructions for Use (IFU) for the above referenced product, the end user is instructed to inspect the package for damage and, if present, to discard the device. Operating room staff should conduct this packaging inspection for any breach in the outer and inner packaging. Performing this inspection should mitigate this potential hazard. In the unlikely event the packaging is not inspected, there is a potential that a non-sterile implant will be implanted which may result in a post-operative infection.
Recall Action	Hazard Alert
Recall Action Instructions	All affected products in the market have been recorded as being used. Stryker has decided that the implanting and treating physicians should be made aware of this issue to facilitate review of their patients for this issue as part of the normal post-operative course of treatment. Stryker recognises that the implanting and treating physicians are in the best position to exercise the necessary medical judgment for their patients . This action has been closed-out on 05/12/2016.
Contact Information	02 9467 1052 - Stryker