Voluntary recall of 15 lots of ACETABULAR CUP INTRODUCER (32mm) due to issue of the nylon ejector slug melting during the autoclave process

Johnson & Johnson Pte Ltd would like to inform healthcare professionals of a voluntary recall of 15 lots of ACETABULAR CUP INTRODUCER (32mm) because the nylon ejector slug may melt during the autoclave process. This may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement. Healthcare professionals are advised to cease using the affected devices and return them immediately to Johnson & Johnson Pte Ltd. Surgeons are recommended to discuss potential clinical implications and risks with symptomatic patients, and provide follow up recommendations. Prophylactic revision in the absence of symptoms in patients on whom these devices may have been used is not recommended. 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.