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U.S. Department of Health and Human Services

Safety

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Smith & Nephew RF Denervation Probes

Audience: Hospital risk managers, surgical service personnel

[Posted 03/27/2007] FDA notified healthcare professionals of a nationwide Class I recall of RF Denervation probes used with the Smith & Nephew Electrothermal 20S Spine System in RF heat lesion procedures for the relief of pain. The product was mislabeled. The device is a non-sterile (not germ free) device but it was labeled incorrectly as sterile (germ-free). It is a reusable item that is intended to be sterilized (made germ-free) by the medical facility prior to each use, including initial use. This error may result in infections with associated risks including, organ failure and/or death.

[March 27, 2007 - Recall Notice - FDA]
[March 26, 2007 - Press Release - Smith & Nephew]