Encision Inc., a medical device company owning patented surgical technology that is emerging as a standard of care in minimally-invasive surgery, has recalled certain electrode tips used in its AEM® surgical systems. It was learned that certain tips could become susceptible to breaking off as a consequence of aggressive cleaning of the tip. The tips covered by the voluntary recall are Encision’s ES388X Series Reusable Suction-Irrigation Electrodes.
All of the affected instruments will be replaced at no charge to the customer. Encision has contacted customers by letter and will provide them with replacement instruments as soon as they are available. The Company has developed a replacement instrument and is currently working with the FDA to obtain approval of the replacement. Until the FDA provides its approval, the company will not be able to provide replacement products to customers. In the interim, the company has provided customers with the prior version of the product, which it says is not susceptible to the same issues as the recalled product. Customers may contact the company’s customer service at 800-998-0986.
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