Voluntary lot-specific recall of MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7

Transmedic Pte Ltd would like to inform healthcare professionals of an urgent, voluntary, lot-specific recall of MCK TIBIAL BASEPLATE-RM/LL-SZ 2 and MCK TIBIAL BASEPLATE-RM/LL-SZ 7. MAKO Surgical Corp (a division of Stryker) has discovered that the packaging of certain sizes and lots of the above-referenced devices may contain the incorrect device and/or label. The difference in Size 2 RM/LL implant and Size 7 RM/LL implant is easily identified by the end user and hence, affected devices would not likely be implanted as the discrepancy would be obvious. Healthcare professionals are advised on the list of known hazards potentially associated with the use of the referenced devices, the risk mitigation measures and that technical and medical assessments are currently underway to determine any further potential hazards. 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.