Field Safety Notice Integra LifeSciences Product Recall Biologic mesh (ICN 2157)

Alert:

• Integra Lifesciences has issued a Field Safety Notice recalling a range of fixation devices as listed in Appendix 1.
• Based on an internal investigation, Integra LifeSciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results.
• Higher levels of endotoxins can induce an immune response, leading to a post operative fever.
• If you have already implanted or used the products affected by this recall, the recommendation is to monitor the patient for fever symptoms in the immediate postoperative period according to the standard hospital or clinician protocol. If these harms do occur, they would begin to present themselves after the first few days or within a few weeks post-operative care.

Products Affected:

• The product codes currently suspended, are normally available on NHS Supply Chain’s eDirect Service. A resolution date is not yet available, and this ICN will be updated when we have more information.
• Please refer to Appendix 1 in the Field Safety Notice and the attached product listing for full details including potential alternative devices.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share them with all affected product users.
• Complete the Customer Response Form in Appendix 2 of the Field Safety Notice and return it to the distributor Q Medical Technologies email: Info@qmedical.co.uk
• For further information or assistance please telephone Q Medical on:0845 1949284
• Please also contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products in your possession, including NPC, Lot numbers and quantity stating whether boxes or eaches.
• Your Customer Service Advisor will give you a unique CMS log number and raise the appropriate credit on your behalf following confirmation of collection by Q Medical.
• Please note Q Medical advise they have emailed all customers, if you have already received and actioned this field safety notice there is no need to take any further action.
• Where potential alternatives are identified, customers are advised to consult their own clinical experts to ensure suitability for your organisation’s use of these products

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Please be aware that in the event of a Field Safety Notice/Product Recall, we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.