Voluntary recall for Flexible Shaft Ø 8.0mm, L 360 mm

Johnson & Johnson Pte Ltd would like to notify healthcare professionals of a voluntary recall by Synthes GmbH for the Flexible Shaft Ø 8.0mm, L 360 mm for Extraction System for Solid Medullary Nails. This recall affects all lots distributed prior to 03 May 2016. The affected device did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. This could be attributed to the corrosion of the device at solder points and could potentially be reproduced during use and reprocessing. Should the device develop corrosion while in use, the patient could be briefly exposed to potentially cytotoxic material, which may result in adverse tissue reactions and surgical delays. Healthcare professionals are advised to monitor patients who have been exposed to the affected device for any adverse tissue reactions. 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.