Kugel Mesh Hernia Patch Recall
Bard Announces Recall of Composix® Kugel® Mesh X-Large Patch
1/13/2006 — MURRAY HILL, NJ — C. R. Bard, Inc. (NYSE-BCR) today announced that it is voluntarily recalling its Bard Composix Kugel Mesh X-Large Patch intended for ventral hernia repair. This recall does not affect any of the company’s other hernia repair products.
The company is initiating this recall due to reports that the device’s plastic coil ring, designed to aid in its deployment, may not withstand the increased stress associated with certain surgical placement techniques. The company has received 24 reports of broken rings out of approximately 32,000 units sold since 2002, a rate of approximately 0.08%.
The products affected by this recall were distributed to customers worldwide. Bard has notified affected customers and the appropriate regulatory agencies, including the U.S. Food and Drug Administration.
The three product codes involved generated sales of approximately $11 million in 2005, before the effect of the recall.
The company expects to record a sales reduction and related charges associated with the recall in the 2005 fourth quarter and these adjustments will cause the company’s results to be below previously stated guidance for the quarter. The company remains comfortable with its previously stated guidance for 2006 of constant currency net sales growth of between 9 percent and 10 percent and diluted earnings per share equivalent to a minimum of $3.42, excluding the effect of FAS123R.
