Recall of FOOTPRINT Ultra PK Suture Anchors

A Dear Healthcare Professional Letter has been issued by Smith & Nephew Pte Ltd to inform healthcare professionals of a voluntary recall for specific batches of FOOTPRINT Ultra PK Suture Anchors. This voluntary recall was initiated because the space between the device and the packaging permits excessive movement, which could potentially lead to the displacement of the anchor’s tip protector allowing the tip of the anchor to create a sterile breach. In the most likely scenario, the user would identify the pouch breach prior to use. In the worst-case, the breach is not noticed and a non-sterile device is used, resulting in potential biologic response such as infection. There have been no reports of the worst-case so far. No additional patient follow-up is required for patients implanted with affected devices as standard patient follow-up is considered sufficient. 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.