Voluntary recall of rHead and uHead stem implants

Small Bone Innovations Inc. (SBi) would like to inform healthcare professionals of a voluntary recall of the rHead and uHead Stem Implants due to a breach in sterile packaging. SBi has found an increased risk of implants breaching the sterile pouches inside the shrink wrapped box. The breach of sterile pouches has been determined to be due to the size, shape and weight of the metal stems in combination with a change in business model. A breached package is easily recognized by the user. To date, SBi has not received any reports of patient injuries or adverse events. As a precautionary measure, SBi is initiating a voluntary recall of the rHead and uHead Stem Implants. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more 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.