Recall of lot-specific MAGEC® System due to potentially compromised sterile barrier system

A Dear Healthcare Professional Letter has been issued by NuVasive South East Asia Pte Ltd to inform healthcare professionals that NuVasive Specialized Orthopedics, Inc. is conducting a lot-specific recall of the MAGEC® system manufactured from April 2021 to 17 October 2022. Based on the investigation, a small population (3.8%) of packaged units have an undersized O-ring gland diameter that can affect the O-ring compression when the hard cap is affixed to the packaging tube. This lack of full compression can create a situation where the integrity of the container closure system is compromised, potentially impacting the sterile barrier system. For any affected devices that have been implanted, there are no specific patient monitoring instructions related to this recall that are recommended beyond existing follow-up schedules. Healthcare professionals are advised to return all affected unused devices to NuVasive. 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.