Voluntary recall for 3.5mm Locking Screws – 2 lots of Stardrive®, Self·Tapping & 5 lots of Hex Drive, Self·Tapping
Healthcare professional
Medical devices
20 April 2016
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Johnson & Johnson Pte Ltd has issued a Dear Healthcare Professional Letter to inform healthcare professionals of the voluntary recall of 2 lots of 3.5mm Stardrive Self-tapping Locking Screw and 5 lots of Hex Drive Self-tapping Locking Screw. The product owner, Synthes GmbH, is initiating this recall as packages of the identified part and lot numbers of Stardrive and Hex Drive Locking Screws include the incorrect screws with incorrect labels, and part and lot numbers etchings. The difference between the two screws would likely be visually detected as the screw head would not match the recess or fit onto the screwdriver. If the discrepancy is identified during surgery, there may be a surgical delay while a replacement screw is procured. Healthcare professionals are advised to return the affected screws to Johnson & Johnson Pte Ltd. Healthcare professionals are advised to 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.
