Recall of specific lots of Suture-Based Repair Systems by Smith & Nephew due to manufacturing issue that may affect product sterility

A Dear Healthcare Professional Letter has been issued by Smith & Nephew, Inc to inform healthcare professionals regarding a recall of specific lots of Suture-Based Repair Systems (with trade names TWINFIX, ULTRA FAST-FIX, BIORAPTOR, RAPTORMITE, OSTEORAPTOR, TWINFIX ULTRA, HEALICOIL, or MICRORAPTOR). An issue has been identified in product packaging process which may result in an improper or incomplete seal of the pouch for the Suture-Based Repair Systems and compromise product sterility. If the breach of pouch sterile barrier is not detected and the devices are used in procedures, they could potentially cause infection. Healthcare professionals are advised to stop using the affected devices and to return all unused affected units to Smith & Nephew. Healthcare professionals who have treated patients using the affected devices are advised to maintain their routine patient follow-up protocol. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

28 Sep 2020

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on 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://www.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 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.