We would like to bring to your attention that the SafeTPen devices have been temporarily withdrawn from the UK market by Canonbury, the distributor, and Podonics, the manufacturer, in conjunction with the Medicines and Healthcare products Regulatory Agency (MHRA). This decision was made in response to a UK regulatory requirement.
The Safe-T-Pen was designed to provide clinicians and patients with maximum safety during nail surgery procedures. It was initially launched as a Class I Medical Device but has now been determined to require Class IIa classification due to potential contact with broken skin during some matrixectomies.
Canonbury will issue a Field Safety Notice (FSN) on Monday, 27th February, 2023, to all customers who have purchased the devices within the last few months, requesting that they immediately cease using the product. The completed FSN needs to be returned to Canonbury, who will arrange to collect any unused devices and issue pro-rata credits accordingly.
We understand that many thousands of Safe-T-Pen devices have been sold throughout the UK, and for the majority of users, it has become their preferred device for nail matrixectomy. However, the product will not be available for purchase until it has been suitably reclassified.
We encourage all of our readers to check whether they have purchased Safe-T-Pen devices recently and comply with the instructions given in the FSN. Please note that if you receive an FSN, it is crucial that you return the completed form, even if you have no stock left, as this will allow Canonbury to track understanding and acceptance in accordance with UK regulatory requirements for medical devices.
If you have any queries regard this withdrawal you can contact Canonbury Healthcare direct via compliance@canonbury.com the original press release can be found here:
https://www.canonbury.com/blog/important-communication-regarding-safetpen.html
Please feel free to share this article with any colleagues who may have purchased the devices.
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