Recall of selected Biomet Endobon® Xenograft Granules due to potential risks of tissue irritation and infection
Healthcare professional
Medical devices
4 April 2016
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Asia Implant Support & Services would like to inform healthcare professionals of a voluntary recall of selected Biomet Endobon®Xenograft Granules products as limited results indicated that the product’s cytotoxicity tests did not pass at 36 months (real-time) aging. Implantation of the device with less than 18 months of its shelf life remaining may increase the patient’s risk of soft tissue irritation and infection. Biomet has initiated a recall of all lots supplied with 36 months shelf life. Healthcare professionals are advised to identify and return all affected products to Asia Implant Support & Services. 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.
