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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00371-1
Product Name/Description	Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails) Part number: 357.399 Lot Numbers: All lot numbers prior to 7527384 ARTG Number: 203637
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/03/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The wrong material (Stainless Steel) is indicated on the product label. The product is made of Cobalt Chrome. There is a potential harm associated with the mislabelled product for adverse tissue reaction especially if the guidewire breaks during surgery and a fragment is retained.
Recall Action	Recall for Product Correction
Recall Action Instructions	Synthes is notifying their customers of the incorrect information on the product labels and is providing additional safety advice to mitigate the risk of cobalt sensitivity reactions.
Contact Information	1800 796 8435 - Synthes Customer Service