Voluntary Recall of Lateral rHead Heads and Head Assemblies for Uni-Elbow™ Systems and ReMotion™ Total Wrist Distal Radial Components

Small Bone Innovations Inc. (SBi) would like to inform healthcare professionals of a voluntary recall of the Lateral rHead Heads and Head Assemblies for Uni-Elbow™ Systems, and ReMotion™ Total Wrist Distal Radial Components. SBi is initiating this recall because of an increased risk of the implants breaching the sterile pouches inside the shrink wrapped boxes. The breach of the sterile pouches has been determined to be due to the size, shape and weight of the metal stems in combination with a change in a business model. If the breached package is not recognized by the user, there is a major risk of delay or rescheduling of the surgery. SBi has advised healthcare professionals to identify and quarantine the affected devices. Healthcare professionals are advised to refer to the Dear Healthcare Professional 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.