Recall of specific lots of OsteoMed/ Acumed 1.6mm x 4mm Profile Zero Auto-Drive Screws due to a manufacturing error

A Dear Healthcare Professional Letter has been issued by Humedical (S) Pte Ltd to inform healthcare professionals of the voluntary recall of six lots of 1.6mm x 4mm Profile Zero Auto-Drive Screws Part Number 218-1604 (non-sterile) and 218-1604-SP-10 (sterile) due to a manufacturing error. These packs may potentially contain screws that were manufactured with an undersized screw head. In the event that a surgeon uses a non-conforming 218-1604 screw with an undersized screw head diameter, the plate may ‘give’ enough during insertion to allow the screw to pass through the plate. There is also the potential for loss of fixation post-surgery if a screw with an undersized head was successfully inserted. Healthcare professionals are advised to immediately cease use, quarantine and return all the affected products to Humedical (S) Pte Ltd. For patients who have been implanted with the affected products, healthcare professionals are advised to exercise medical judgment for their patients and  make the final decision on indications for additional treatment depending on the patient’s symptoms. 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 ↗ (opens in new tab) 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.