Recall of specific lots of LFIT™ Anatomic CoCr V40™ Femoral Heads due to tamper lock failure

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.

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on 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://www.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 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.