PLAINSBORO, N.J., April 10, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that on April 10, 2013 it initiated a voluntary recall of certain products manufactured in its Añasco, Puerto Rico facility between December 2010 and May 2011 and between November 2012 and March 2013. Specific lots of these products, including DuraGen® Dural Graft Matrix products, have been recalled because the Company identified that there may have been deviations from approved processes in their production.
There have been no reports of adverse patient events attributable to the products subject to the recall. The Company continues to manufacture all the affected products in, and distribute from, its Añasco facility.
The recall will affect Integra's revenues and profits for the first and second quarters of 2013.Taking into account reductions in revenue directly resulting from the recall and lower than expected sales because of product shortages, the Company expects that its revenues during the first quarter will be lower than anticipated by approximately $8 million to $11 million. Accordingly, the Company is anticipating revenues for the first quarter of 2013 to be in the range of $194 million to $197 million. In addition, the Company expects to record incremental expense during the first quarter, including scrap related to affected finished good products that were not released to customers, affected work in process, and legal and consulting costs, of approximately $2.5 million to $4.5 million, which it will exclude from the calculation of adjusted earnings per share. The Company now expects adjusted diluted earnings per share to be in the range of $0.30 to $0.40 for the first quarter of 2013. Estimates of the adjustments to income before taxes are set forth in the table at the end of this press release. The Company expects GAAP diluted loss per share to be in the range of ($0.30) to ($0.08) for the first quarter of 2013.