Voluntary recall of selected lots of dental abutment products and accessories from Biomet 3i
Healthcare professional
Medical devices
26 January 2016
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Asia Implant Support & Services would like to inform healthcare professionals of a voluntary recall of selected lots of dental abutment products and accessories from Biomet 3i as a limited number of product pouches may not have been sealed during packaging. To date, the occurrence rate of a pouch not being sealed during packaging is approximately 0.008%. In the event the product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and/or the component may be missing. Healthcare professionals are informed to return the affected products to Asia Implant Support & Services and monitor patients implanted with affected devices as per routine follow-up protocol. 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.
