Urgent Medical Device Recall of StageOne™ and StageOne™ Select Bone Cement Spacer Molds

A Dear Healthcare Professional Letter has been issued by Zimmer Biomet to inform healthcare professionals of an urgent recall of StageOne^™ and StageOne^™ Select Bone Cement Spacer Molds due to potentially insufficient cleaning process or inadequate process monitoring for cleaning parameters. All lots expiring prior to February 28, 2030 are affected by the recall. Use of or exposure to the affected medical devices may result in adverse local tissue reaction, critical pain or ache, or severe systemic reaction to allergen or toxin. These potential long-term risks would likely occur within one year of beginning the two-stage revision. Out of more than 230,000 devices distributed, there have been five global complaints for events associated with the risks. Healthcare professionals are advised that there are no specific patient monitoring instructions related to this recall that are recommended beyond the existing follow-up schedule. Please refer to the 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.