Silimed update - 26-09-2015

by **Charlii** 26th September 2015, 10:42 am

Email recieved from MRHA

MHRA update: Silimed
25 September 2015

Thank you for signing up to this channel. We will be using it to provide the latest information for patients and carers.

Today we issued a medical device alert (MDA) to ensure the clinical community are aware of the actions to take following the suspension of the CE mark for medical devices manufactured by Silimed lndustria de lmplantes Ltda.

This follows information we received from the German medical device regulatory authority on Friday 18 September 2015. A recent inspection of the manufacturing facility by a German notified body identified particles on the surface of some devices.

We are investigating in collaboration with other European regulators and recommend that none of these devices should be implanted until further advice is issued.

EU health regulators have initiated testing of samples of products to establish if there are any health risks. This will be completed as soon as possible.

There has been no indication at this time that these issues will pose a threat to patient safety.

We will continue to provide updates via this channel as soon as new information becomes available.

Link to the full Medical Health Alert
https://www.gov.uk/drug-device-alerts/implantable-medical-devices-manufactured-by-silimed-temporary-suspension-of-the-ce-certificate