In line with our business values and our We Care More stance, Canonbury (the distributor) and Podonics (the manufacturer) have decided, in conjunction with the Medicines and Healthcare products Regulatory Agency (MHRA), to temporarily withdraw Safe-T-Pen devices from the UK market. This is purely in response to a UK Regulatory requirement.
The current device was brought to market as a Class I Medical Device, however, following regular dialogue with the MHRA, it was determined that since the product may come into contact with broken skin during some matrixectomies it requires Class IIa classification. The work to achieve this classification has been ongoing for a number of months, however due to the backlog of Medical Device caseloads within UK Approved Bodies this has taken far longer than expected.
The product will be relaunched as soon as possible, once it has been suitably reclassified.
Canonbury will be issuing a Field Safety Notice (FSN) on Monday, 27th February, 2023 to all customers who have purchased the devices within the last few months asking you to cease use immediately; return the completed FSN to us; and we will then arrange to collect any unused devices, issuing pro-rata credits accordingly.
Should you receive a FSN it is important that you return the completed form, regardless of whether you have any stock left, as this allows us to track understanding and acceptance in accordance with UK Regulatory requirements for medical devices.
The Safe-T-pen was designed to give clinicians and patients maximum safety during a nail surgery procedure . Many thousands of Safe-T-Pen have been sold throughout the UK and for the majority of our customers is their preferred device for nail matrixectomy. We are, therefore, genuinely sorry for any inconvenience that this may cause, and are working hard with our UK Approved Body to complete the necessary paperwork to be able to place the product back on the market.
If you have any questions in relation to this communication, please contact us via email in the first instance at [email protected]. We will use any questions received to create a further update and this will be posted to our website.