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Class 1 Medical Device Recall - Smith & Nephew, Inc. Radiofrequency Denervation Probes


Posted on Mar 29, 2007

The RF Denervation probe is used for radiofrequency lesion procedures for the relief of chronic pain by applying heat to the nerves. 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. For more information, follow the link below.

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