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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00002-2
Product Name/Description	Guide Wires and K-Wires for T2 and Gamma Nailing Systems Catalogue numbers: 01520218S,12106450,18060050S,18060080S,18060083S,18060084S, 18060085S, 18060090S, 18060093S, 18061250S, 18061417S, 18063030S, 18063031S Multiple Lot Numbers affected ARTG Number: 190236
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	4/01/2016
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	It has been discovered that the seal integrity of the pouch may be decreased. A potential capillary defect in the sealing could potentially lead to the product becoming unsterile, which could result in an infection. No injury or harm has been reported for this event so far.
Recall Action	Recall
Recall Action Instructions	The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 19/03/2018.
Contact Information	02 9467 1047 - Stryker