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Health Sciences Authority
Dear Healthcare Professional Letters

Updates to Instructions for Use of Precice Intramedullary Limb Lengthening System

Audiences

Healthcare professional

Industry member

Product type

Medical devices

12 November 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

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.

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.

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