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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00362-1
Product Name/Description Confidence Spinal Cement System Kit

Product Number: 283913000
Affected Lot Numbers: HPBB0R, HPBB4R, HPBBWM, HPCB67, HPCB75 & HPCBM1
ARTG Number: 152824
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/04/2013
Responsible Entity Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue Complaints have been received involving product currently in distribution in which the customer reports that during injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
Recall Action Recall
Recall Action Instructions Johnson & Johnson is recalling the affected product.
Contact Information 1300 562 711 - JJM Customer Service