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Health Sciences Authority
Dear Healthcare Professional Letters

Voluntary recall of all lots of the SIGMA® HP PFJ Cemented Trochlear Implants due to elevated revision rates

Audiences

Healthcare professional

Product type

Medical devices

19 April 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Johnson & Johnson Medical Singapore would like to inform healthcare professionals of a voluntary recall for all lots of the SIGMA® HP PFJ Cemented Trochlear Implants due to elevated revision rates observed from the company’s post market surveillance. Any further distribution or use of the affected implants is to be ceased as the affected device has been discontinued. Healthcare professionals are informed of the possible effects of using the affected device and advised to discuss the potential clinical implications and risks with symptomatic patients who had received the affected implants. Please refer to the letter for more 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.

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