Voluntary recall for specific lots of Locking Screws Stardrive® Ø 2.4 mm, self-tapping, length 12 mm, Titanium-Alloy-Niobium Alloy

Johnson & Johnson Pte Ltd would like to inform healthcare professionals of the recall of specific lots of Locking Screws Stardrive^® Ø 2.4 mm, self-tapping, length 12 mm, Titanium-Alloy-Niobium Alloy. The product owner, Synthes GmbH, is initiating this recall as the affected Locking Screws Stardrive^® can break between the head and the shaft. This was due to the neck feature being too close to the Stardrive^® feature, leaving a thin wall between the neck and drive. In the event that a screw breaks during insertion or removal, a surgical delay may occur as the surgeon attempts to remove the shaft or fragment from the bone. If the implant of a partially broken or fractured screw goes unnoticed, the patient may present at a later time with pain due to a broken or loosened device. Healthcare professionals are advised to conduct their regular patient follow-ups and return all affected screws that are unused to Johnson & Johnson Pte Ltd. 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.