Surgimend Product Recall
Information about a product recall issued on the 26th May 2023
The ABS would like to draw its members’ attention to a product recall, which has been issued in relation to Surgimend:
Integra LifeSciences is voluntarily issuing a Field Safety Notice for Surgimend®PRS, Surgimend®PRS Meshed, Surgimend®, Surgimend®MP, PriMatrix®Ag products distributed from 1st March 2018 to date.
Based on internal investigation, Integra LifeSciences has identified issues with in-process and finished goods endotoxin testing that may result in out of specification endotoxin results.
The risks to health are indicated as potential harms due to high levels of endotoxins may include low-grade fever, inflammation, and/or inflammatory response leading to fever (pyrexia), and/or surgical intervention/ revision surgery.
If products affected by the recall have already been implanted or used it is recommended that the patient is monitored for a fever in the immediate postoperative period according to the standard hospital or clinician protocol. If these harms do occur, they would most likely begin to present themselves after the first few days to within a few weeks post-operative care.
Units are being sent a form to complete to confirm that they have received the Safety Notice. It can also be downloaded below.
Download the Integra Product Recall here
Download the Integra Field Safety Notice here (Including the form for units to return to confirm that they are aware of the Safety Notice)
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