Recall of specific lots of LFIT™ Anatomic CoCr V40™ Femoral Heads due to tamper lock failure
Healthcare professional
Medical devices
13 October 2016
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Stryker Singapore Pte Ltd would like to inform healthcare professionals of the voluntary recall for specific lots of the LFIT™ Anatomic CoCr V40™ Femoral Heads. Stryker has received higher than expected complaints of taper lock failure for specific lots of the affected LFIT™ Anatomic CoCr V40™ Femoral Heads manufactured prior to 2011. The potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, excessive metallic debris, insufficient ROM, insufficient soft tissue tension, noise, loss of implant-bone fixation strength, excessive wear debris (polymeric) and implant construct with a shortened neck length. Healthcare professionals are advised to continue to follow up with patients implanted with LFIT™ Anatomic CoCr V40™ Femoral Heads as per the normal 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.
