Integra LifeSciences Holdings Corporation has 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.
This sounds like one of those recalls that is more attributable to deviations from approved processes, there having been no reports of adverse patient events. The Company continues to manufacture all the affected products in, and distribute from, its Añasco facility.
However, the company has admitted that the recall will affect its 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.
Furthermore Integra says it expects it will not be able to meet all the demand for the affected products during the second quarter of 2013. The Company now expects that consolidated revenues for the second quarter of 2013 will be between $205 million and $211 million.
Source: Integra Lifesciences Holdings Corp.