UK suspension lifted for NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems
All PRECICE System devices were subject to a device recall notification by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021 (2020/012/009/226/001). The MHRA was concerned that that there was insufficient information to confirm the long-term biological safety of unintended exposure to internal components and the leaching of hazardous chemicals from PRECICE as per the intended use. Furthermore, despite children and adolescents being the main patient group, these devices had not been validated by NSO for use in these populations.
Following representations from members, the BOA had raised the suspension with the MHRA.
The MHRA has now 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. Any use of this device in non-adult populations in the UK is considered ‘off-label’ use.
Full details can be viewed here.