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 |
|
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 |