Current SafeTPen status
SafeTPen has been relaunched in the UK. Canonbury’s current SafeTPen information identifies it as a Class IIa medical device and says it has undergone a further conformity assessment. Canonbury says the device design remains unchanged.
This article originally reported the 2023 withdrawal. The historical notice below should not be read as a statement that all currently supplied SafeTPen products remain withdrawn.
If you still hold stock supplied before the withdrawal, ask Canonbury for advice about that stock and any outstanding Field Safety Notice. A relaunch announcement does not establish that older stock can be used.
For current product information, instructions and supply enquiries, consult Canonbury’s SafeTPen page.
Background: the 2023 withdrawal
In February 2023, Canonbury and Podonics temporarily withdrew SafeTPen from the UK market in conjunction with the Medicines and Healthcare products Regulatory Agency (MHRA). The product had initially been placed on the market as a Class I medical device but was determined to require Class IIa classification because of potential contact with broken skin during some matrixectomies.
Canonbury issued a Field Safety Notice to affected customers, asking them to stop using the product, return the completed notice and arrange the return of unused devices. This information records the position in 2023 and should not replace current, stock-specific advice from Canonbury.
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