25 May 2023
FSN: Integra Product Recall – SurgiMend
SurgiMend is to be removed from use with immediate effect.
We have been advised by our Supplier, Integra Lifesciences, that they have registered an FSCA (Field Safety Corrective Action) with MHRA (Medicines and Healthcare products Regulatory Agency) and they are issuing a Field Safety Notice (FSN), which includes a full worldwide voluntary product recall of medical devices including SurgiMend.
The FSCA/FSN is following an internal investigation process that was conducted at the Integra Boston Facility whereby deviations during endotoxin testing were found, which may have resulted in the release of products with higher levels of endotoxins than permitted by the product specifications. Higher levels of endotoxins can induce an immune response, leading to a post-operative fever.
Our Administration team is currently liaising with all customers to ensure all devices are collected and returned to head office. Please use the contact details below if you require assistance or further information.
Integra are working extremely hard to ensure that they can fulfill the requirements of the endotoxin testing and place their device back into the marketplace. We will update our website and customers with any changes to this situation as they arise.
We thank you for your support during this time.
Kristi Pillans MSc
Group Director for Quality & Regulatory Affairs
Person Responsible for Regulatory Compliance (PRRC)
Product Recall Contact Information
Q Medical Technologies Ltd
Unit 1a Summerlands Trading Estate
Cumbria LA8 0FB
Tel: 0845 1949284
Please be advised that due to the Integra FSN & Recall we have had to cancel the following:
- Integra Masterclass 4th-5th June 2023
- Accelerating the Consultant 7th-8th June 2023
- Integra Academy September
We have also had to withdraw support for the following, however they are still planned to go ahead:
- Royal Free Oncoplastic Course 15th-16th June
- TIG Fellow Course 23rd June 2023
- ICENI CAWR 17th-18th July 2023