Voluntary Recall of CONFIDENCE™ Spinal Cement System 7cc Kit, CONFIDENCE™ Spinal Cement system 11cc Plus Kit and CONFIDENCE™ Spinal Cement System Kit

Johnson & Johnson Medical Singapore would like to inform healthcare professionals that DePuy Spine, Inc has received a total of 15 reports overseas relating to a loss of pressure in the hydraulic pump and inability to continue to inject cement due to the water leaking past the piston within the pump body. CONFIDENCE™ Spinal Cement System is intended for percutaneous delivery of CONFIDENCE™ Spinal Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Although no reports of patient injury were received as a result of this product issue, the hydraulic pump failure could result in delays to the surgical procedure as additional time is required to prepare another kit or the termination of the planned surgical procedure. As a precautionary measure, DePuy Spine has initiated a voluntary recall of the CONFIDENCE™ Spinal Cement System. Healthcare professionals are advised to refer to the letter for the details. Published: 3 May 2013

Dear Healthcare Professional Letters