Recall of selected lots of STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device that do not meet internal testing specifications

A Dear Healthcare Professional Letter has been issued by Johnson & Johnson Medical Singapore to inform healthcare professionals of the voluntary recall of specific product codes and lots of STRATAFIX^™ Spiral PDS^™ Plus Knotless Tissue Control Device as they do not meet certain internal testing specifications. Ethicon has determined that no impact to the device’s clinical performance or overall product risk/benefit is expected. To date, Ethicon has not received any complaints or adverse events associated with the product lot subjected to this voluntary recall. Healthcare professionals are advised to remove and return all unused units of the affected devices to Johnson & Johnson Medical Singapore. Healthcare professionals who have treated patients using the affected devices are advised to follow up with these patients post-operatively in the usual manner with no additional action required. Please refer to 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.