Smith & Nephew Electrothermal Spine System Probe Recall

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete MedWatch 2007 Safety summary, including a link to the
FDA recall notice and firm press release, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes