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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00017-1
Product Name/Description	Quadra Trial Broach size 0 Lot numbers: 074696, 074878, 074879, 075022, 075023, 075056, 075064, 084000, 084001, 084326, 084409, 084743, 084753, 084815, 084816, 085202, 085318, 085455, 085690
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/01/2013
Responsible Entity	Medacta Australia Pty Ltd
Reason/Issue	The manufacturer has advised that the tip of a Quadra broach (size 0) broke in the intra-medullary channel while broaching, during a total hip replacement surgery. This recall action was carried out prior to approval of the recall strategy by the TGA.
Recall Action	Recall
Recall Action Instructions	Medacta Australia is requesting users return affected devices to Medacta for replacement with unaffected product.
Contact Information	02 9420 2944 - Medacta Australia