Integra LifeSciences Holdings Corp. (IART) Wednesday said it has initiated a voluntary recall of certain specific lots of products, including DuraGen Dural Graft Matrix products, as the company identified that there may have been deviations from approved processes in their production.
These products were manufactured in its Anasco, Puerto Rico facility between December 2010 and May 2011 and between November 2012 and March 2013. The recall will affect Integra's profits for the first and second quarter.
There were no reports of adverse patient events attributable to the products subject to the recall, and the affected products continues to be manufactured in, and distribute from, the Anasco facility.
For the first-quarter, the company currently forecast a loss in the range of $0.30 to $0.08 per share, with adjusted earnings in the order of $0.30 to $0.40 per share. Revenues are projected in a range of $194 million to $197 million.
Analysts, based on consensus, currently expect the company to earn $0.69 per share on revenues of $204.69 million.
The company also expects to record incremental expense of approximately $2.5 million to $4.5 million, relating to the recall, during the quarter.
Meanwhile, the company anticipates second-quarter revenues in the range of $205 million to $211 million. Analysts expect revenues of $219.54 million.
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