Samarys™ Peek Anterior Cervical Cage and potential incident risk of missing or improperly secured/incorrectly positioned gold wire markers

Scient’x SAS France would like to notify healthcare professionals of the recall of selected lots of Samarys™ Peek Anterior Cervical Cage due to a non-conformity relevant to the gold wire markers. Missing or improperly secured/incorrectly positioned gold wire markers may protrude 1-2mm inside or outside the cage. Potential hazards include positioning errors that may lead to neurological injury, local inflammation of surrounding tissues in contact with wire and migration of gold wires in the surrounding tissues. Healthcare professionals are advised to return all affected products to Scient’x Asia Pacific Pte Ltd. 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.