March 28, 2007
FDA MedWatch – Smith & Nephew Radio Frequency (RF) Denervation Probes: class 1 nationwide recall due to mislabeling as sterile
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
