—#50152

Product

RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271

FDA product code: GXI — Probe, Radiofrequency Lesion
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K034012
Affected lot / code info: Lot Numbers: 602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999

Why it was recalled

Product is non-sterile but labeled incorrectly as sterile.

Root cause (FDA determination)

Other

Action the firm took

Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.

Timeline

Recall initiated: 2007-01-19
Posted by FDA: 2007-03-29
Terminated: 2008-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50152. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.