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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00611-1
Product Name/Description	Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire) Part Number: 357.399 Lot Numbers: 7560756, 7584396, 7594896, 7560829, 7562800, 7589236, 7594058, 7583667, 7589696 and 7594057 ARTG Number: 203637
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	6/06/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The packaging for the selected part and lot numbers of the Guide Wire Ø 3.2 mm, length 400 mm were mislabelled with an incorrect material. The label incorrectly declares 'Molybdenum' instead of Wolfram and Nickel as alloyed elements. The correct label should indicate “CoCrWNi Alloy”. During the normal course of the surgery, the risk of adverse tissue reaction is decreased as the guide wire is not retained in the body after the procedure is completed. In the case of a broken guide wire, a fragment may be retained after surgery. In this case, a patient with sensitivity to nickel could develop a moderate adverse tissue reaction.
Recall Action	Recall
Recall Action Instructions	Customers are advised to immediately isolate the affected stock for returning to Synthes Australia.
Contact Information	1800 796 8437 - Synthes Australia