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IRIC safety alert

MHRA Device Safety Information – MDSI2306

Published on 12 April 2023

From: Health Facilities Scotland

MDSI2306 - NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted



The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom) can now be used in adults in the UK. NSO has agreed to meet a set of conditions to effectively monitor the long-term biological safety of the devices.

Please note: the CE marks for PRECICE Biodur systems (Bone Transport, Stryde and Plate) have NOT been reinstated and these devices remain suspended from the UK market.