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

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.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.