Voluntary Recall of CONFIDENCE™ Spinal Cement System 5cc Kit, CONFIDENCE™ Spinal Cement System 7cc Kit, CONFIDENCE™ Spinal Cement system 11cc Plus Kit and CONFIDENCE™ Spinal Cement System Kit
Healthcare professional
Medical devices
29 January 2013
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Johnson & Johnson Medical Singapore would like to inform healthcare professionals that DePuy Spine Inc. is voluntarily recalling all lots of CONFIDENCE™ Spinal Cement System 5cc Kit, CONFIDENCE™ Spinal Cement System 7cc Kit, CONFIDENE™ Spinal Cement system 11cc Plus Kit and CONFIDENCE™ Spinal Cement System Kit. The recall is due to the difficulty or an inability to complete the mixing process of the CONFIDENCE™ Spinal Cement , resulting in the mixer being “jammed” or “stuck” and nearly impossible to turn. This could result in surgical delay, in order to prepare another kit or the inability to complete the procedure if an additional kit is not available, thereby exposing the patient to additional anesthesia in another surgical procedure. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for details on the recall process.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.
