Urgent Medical Device Recall of Segmental System Proximal Femoral Component 38mm Offset
Healthcare professional
Medical devices
13 April 2018
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Zimmer Pte Ltd would like to inform healthcare professionals of the voluntary recall of selected lots of Segmental System Proximal Femoral Component 38mm Offset due to one complaint received alleging that the hole on its superior lateral aspect contained debris. Results of an investigation determined the debris to be from the machining process, where subsequent cleaning process did not adequately remove the debris. Potential health risk include inflammation or osteolysis as a long range health consequence. Healthcare professionals are advised to quarantine all affected products and return them to Zimmer Pte Ltd. 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.
