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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00324-1
Product Name/Description	DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length Part number: 280.XXXS DHS/DCS Screw, Titanium Alloy (TAN), sterile, various length Part number: 480.XXXS Multiple lot numbers affected. ARTG number: 157068
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/04/2013
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	Synthes has two couplings in place for the DHS/DCS Screws, standard with teethed recess and octagonal recess. The pictogram on the labels of the articles shows the wrong coupling. All other information on the label (e.g. coupling description in words) is correct.
Recall Action	Recall
Recall Action Instructions	Depuy Synthes is recalling the affected lots and is replacing them with unaffected units.
Contact Information	1800 796 8437 - Synthes Australia