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Integra LifeSciences Recalls Products From Boston Facility, Takes Financial Hit

 
• By Brian Bossetta

After consulting with the US FDA, Integra Life Sciences initiated a recall of products produced in its Boston Facility. The company expects losses of $22m.

REVENUE LOSS
• Source: Shutterstock

Integra LifeSciences initiated a recall on 23 May of all products manufactured at its Boston facility distributed between 1 March 2018 and 22 May of this year. The company initiated the recall, which includes the surgical repair products SurgiMend, PriMatrix, Revize, and TissueMend, because of endotoxin deviations that could result in higher levels of toxins in the products than are permitted. Higher endotoxins can result in post-operative fever.

The voluntary recall, according to analysis from Wells Fargo, could cost the company some $22m in impairment charges that it plans to record in the quarter ending 30 June....

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