Recall of Cartiva Synthetic Cartilage Implants due to higher occurrence rate of hazards

A Dear Healthcare Professional Letter has been issued by Stryker Singapore Pte Ltd to inform healthcare professionals about the recall of Cartiva Synthetic Cartilage Implants (SCI) due to updated post market safety data. Recently published data and post market reports indicate that patients implanted with Cartiva SCI may experience a higher-than-expected occurrence rate of the following documented hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation. In some cases, Cartiva SCI devices have been observed to be revised/ removed at higher rates than previously observed in the initial Cartiva SCI premarket and post-approval studies. Healthcare professionals are advised to identify, quarantine, and return all affected products. It is also recommended to monitor patients implanted with the affected products for new or worsening symptoms of pain, difficulty walking, skin reactions, stiffness, swelling, or weakness of the joint, as per current protocols. Healthcare professionals are advised to discuss all potential risks identified for Cartiva SCI as well as the benefits and risks of all relevant treatment options with patients. 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.