The MHRA yesterday issued a notice on 20 Jan 2021 about a device recall and suspension of supply to the UK market, which covers all PRECICE Systems by NuVasive Specialized Orthopedics Inc (NSO). NuVasive itself has also issued a Field Safety Notice (FSN). BOA members who use these devices are advised to review the MHRA and NuVasive documentation as follows:
The MHRA recommendations are:
- Do not implant any of the affected PRECICE System devices in the UK.
- If you have any devices remaining on site, remove them from stock and return them to the manufacturer (NSO).
- Review and implement the manufacturer’s clinical advice under the ‘Recommended User Action’ section in the FSN. Contact NSO for clarification of the clinical advice and recommended user actions, if required.
- Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate.