Targeted letter: Implantable orthopaedic devices manufactured by Implants International Ltd trading as Xtremity Solutions Ltd. (DSI/2021/002)
Unknown risks following distribution of product after CE certificate withdrawal
This was a targeted letter sent to specific organisations that the MHRA knows have these devices. It was sent on Wednesday 17 February 2021 and is being published here for information.
I am writing to you concerning the purchase and use of the following implants and associated surgical instruments manufactured by Implants International Ltd., trading as Xtremity Solutions Ltd:
- Roto-Glide Great Toe MTP implant system
- Footlocker midfoot & forefoot plate & screw implants
- Omni-Fix Intramedullary (IM) nail system
These products have not had valid CE certification since 04 September 2019 and therefore any devices manufactured and/or distributed after that date should not be used in the UK. They should be returned to the manufacturer.
The affected devices have not undergone the necessary conformity assessments and their safety and efficacy cannot be assured. These devices should not have been distributed to the UK by the manufacturer after 04 September 2019. After discovery of continued sales, MHRA took further action to prohibit the supply of these devices until further notice.
The MHRA is aware that these devices have been distributed to several hospitals in the UK after 04 September 2019. If these devices have been implanted into patients at your institution, you should consider the need for continued clinical follow-up and monitoring for adverse reactions.
We understand that the manufacturer is currently in the process of obtaining new certification. Once this process has been successfully completed, MHRA will review the prohibition status.
MHRA’s recommendations
Due to the unknown risks of using the devices listed above, MHRA recommends the following:
- Do not implant any of the affected devices listed above.
- If you have any devices remaining on site, remove them from stock and return them to the manufacturer – Implants International Ltd/Xtremity Solutions Ltd.
- Consider the need for continued clinical follow-up and monitoring for adverse reactions in patients who have been implanted with affected product distributed after 04 September 2019.
- Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.
If you have any queries about this letter, please contact:
Manufacturer
Implants International Ltd (trading as Xtremity Solutions)
0164 276 9080 or 07971131281
MHRA
[email protected] quoting MHRA ref: TL/2021/05
Yours sincerely,
Devices Safety and Surveillance Group Medicines and Healthcare products Regulatory Agency