Recall of various legacy Biomet products with elevated levels of bacterial endotoxin and residual debris

A Dear Healthcare Professional Letter has been issued by Zimmer Biomet to inform healthcare professionals regarding a recall of various legacy Biomet products as they were subjected to cleaning processes that could result in elevated levels of bacterial endotoxin and residual debris remaining on the device. Locally, only Comprehensive RVS Mini Baseplate (Item No: 010000589) and Comprehensive RVS Baseplate - 28 MM (Item No: 115330) are supplied in Singapore. Zimmer Biomet has assessed that these elevated levels could result in a local tissue reaction, but the risk of infection is not elevated as the sterility of the devices is not impacted.  Healthcare professionals are advised to return all unused affected units to Zimmer Biomet. Healthcare professionals who have treated patients using the affected devices are advised to follow up with these patients according to their existing follow-up schedules. Please refer to letter for details.

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.