Medical Device Field Safety Notification on Orbital Rim Plate 1.3, curved, 9 holes, Pure Titanium

Johnson & Johnson Pte Ltd would like to inform healthcare professionals of a labelling correction of selected models of the Orbital Rim Plates due to their mislabelling as Orbital Floor Plates. The incorrectly labelled devices will be replaced with devices with correct labels. The mislabelling may result in user dissatisfaction but is not likely to impact the patient. There is no increased harm related to this non-conformance and no new risk to patient is identified. Healthcare professionals are advised to 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.