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

Date Recall Initiated:

January 19, 2007

Product:

Smith & Nephew, Inc. Radiofrequency Denervation Probes (for use only with the Smith & Nephew Inc. ELECTROTHERMAL™ 20S Spine System) for the part numbers and lot numbers listed in the table below.

Use:

The RF Denervation probe is used for radiofrequency lesion procedures for the relief of chronic pain by applying heat to the nerves.

Recalling Firm:

Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Road
Andover, Massachusetts 01810

Reason for Recall:

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.

Public Contact:

Consumers with questions may contact the company at 1-800-343-5717.

FDA District:

New England

FDA Comments:

Smith & Nephew, Inc. has notified its distributors and customers by Federal Express through a letter sent on January 19, 2007. Smith & Nephew, Inc. is arranging for a return and replacement of all recalled products.

For more information about this recall, please see the company’s press release at: http://sev.prnewswire.com/biotechnology /20070326/CLM32626032007-1.html

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that, should this particular malfunction occur, use of the affected product may cause serious injury or death if the problem is not corrected.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at:
  www.fda.gov/MedWatch/getforms.htm.
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD
  20852-9787
• FAX: 1-800-FDA-0178