Voluntary recall for Synthes® Mandible Distractor, Monoaxial and Proximal Foot Plate

Johnson & Johnson Pte Ltd would like to notify healthcare professionals of a voluntary recall by Synthes GmbH regarding the Mandible Distractor, Monoaxial and Proximal Foot Plate. Synthes GmbH is initiating a recall on all lots and selected models of the devices, as the fastener on the Mandible Distractor may become prematurely separated from the Proximal Foot Plate.  In the event that the Mandible Distractor becomes disengaged from the Proximal Foot Plate, there may be a risk of surgical delay or a need for repeat surgery which may pose a risk of local infection in the oral cavity. Healthcare professionals are advised to monitor patients implanted with the affected devices regularly for any signs of device disengagement or loosening. 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.