Recall: Encision voluntarily pulls surgical tips | MassDevice.com On Call

October 17, 2011 by MassDevice staff

Encision Inc. recalls its surgical electrode tips over concerns that they may break during "aggressive cleaning."

MassDevice On Call

MASSDEVICE ON CALL — Encision Inc. (PINK:ECIA) voluntarily recalled electrode tips used with its AEM surgical systems over concerns that the tips could break off as a result of "aggressive cleaning."

The Boulder, Colo.-based laparoscopic device maker said that a replacement instrument has been designed and is undergoing FDA review.

In the mean time, Encision is replacing existing tips with the prior model at no charge to customers, according to a press release.

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In connection with the recall, Encision announced that it recorded a one-time charge of $430,000 for the quarter ended September 30, 2011. That included non-cash charges of $105,000 for removal of affected tips already in inventory and for increasing warranty accruals.

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