Proper assembly of certain Biomet Optipac® products

A Dear Healthcare Professional Letter has been issued by Zimmer Biomet to inform healthcare professionals about the proper assembly of certain Biomet Optipac® products, including Optipac® Refobacin® Bone Cement. Incomplete tightening of the mixing rod when it is assembled with the cylinder during use can lead to an incomplete vacuum within the system, preventing complete release of the monomer liquid into the cylinder. The product cannot be used when the monomer liquid has not entered the cylinder and must be discarded after such occurrence. This may result in non-clinically significant increase of surgical time. The Instructions for Use (IFU) for the affected devices will be updated accordingly. Healthcare professionals are advised to refer to the letter for updated instructions on the assembly process to ensure that the mixing rod is tightened correctly during use. Please refer to the letter for details. 

Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

17 Feb 2025

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.