Updates to Instructions for Use of Precice Intramedullary Limb Lengthening System

A Dear Healthcare Professional Letter has been issued by ConMed Singapore Pte Ltd to inform healthcare professionals of the immediate availability of the Precice Intramedullary Limb Lengthening (IMLL) System with updated Instructions for Use (IFU), as a follow up to the earlier recall of all Precice System devices in February 2021 due to biological assessments gaps. The updated Precice IMLL IFU provides clarification on the target patient population, warnings and potential adverse events that can occur when using the device. Healthcare professionals are advised to consult the updated IFU for both currently implanted and potential Precice IMLL system patients, on an ongoing basis, before and throughout patient treatment. The use of Precice IMLL is not recommended for patients <50lbs or for patients with >2 implanted devices. For patients currently implanted with the device under such conditions, healthcare professionals are advised to assess their treatment progression and consider prompt removal of the device after treatment to minimise potential for implantation risks, risks associated with repetitive surgical interventions, and sub-optimal conversion to alternative therapies mid-treatment. Healthcare professionals are reminded that the Precice IMLL device should be removed after implantation time of no more than a year. Please refer to the letter for details.
Healthcare professional, Industry member, Medical devices
Published:

Dear Healthcare Professional Letters

16 Nov 2021

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). HPP is 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: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

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

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