NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006

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.

PRECICE Titanium Systems – Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom.

Affected lot numbers/serial numbers: Refer to FSN for affected devices.

Manufactured by NuVasive Specialized Orthopedics (NSO)

NSO has agreed to meet a set of conditions to effectively monitor the long-term biological safety of the devices.

The CE marks for PRECICE Biodur systems (Stryde and Plate) have not been reinstated and all PRECICE Biodur systems (Bone Transport, Stryde and Plate) remain suspended from the UK market.

All PRECICE System devices were affected by the following concerns as identified in the previous device recall notification dated 20 January 2021 ref: 2020/012/009/226/001

The MHRA conducted an extensive review of the PRECICE system of devices which found that there was insufficient information to confirm the long-term safety of PRECICE as per the intended use. NSO has now provided sufficient evidence to address this concern as set out below:

The long-term safety of unintended exposure to internal components and the leaching of hazardous chemicals was unknown. Extractable and leachable testing in worst case scenario, without the end cap, has been performed. This evaluation is considered acceptable and scientifically justified and is no longer a concern.

The long-term safety of exposure to metal wear debris was not sufficiently evaluated. NSO has since conducted testing to better define this risk but there remain some gaps in the evidence regarding safety. The MHRA has therefore requested NSO to conduct a post-market clinical follow up study to proactively monitor the risk of exposure to metal wear debris in patients who have these devices implanted. The MHRA will continue to review and assess the safety of the device on an ongoing basis.

Despite children and adolescents being the main patient group, these devices have not been validated by NSO for use in these populations. The PRECICE devices should only be implanted in accordance with the Manufacturer instructions For Use. Any use of this device in non-adult populations is considered ‘off-label’ use.

PRECICE Titanium systems: Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom can now be appropriately selected for use in surgery.

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Stakeholder engagement

Spinal Expert Advisory Group (SEAG)

British Orthopaedic Association (BOA)

NHS England Patient Safety Team

Devolved Administrations

NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted, DSI 2023/006