Z-0663-2007

RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion...

Name: Z-0663-2007 RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2007-01-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-01-19 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number... on 2007-01-19. The reason FDA records is "Product is non-sterile but labeled incorrectly as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0663-2007
Status: Terminated
Initiated: 2007-01-19
Posted: 2007-03-29
Terminated: 2008-01-18
Recalling firm: Smith & Nephew, Inc.
Product: RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271
Product code: GXI Probe, Radiofrequency Lesion
Reason for recall: Product is non-sterile but labeled incorrectly as sterile.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
Quantity in commerce: 338 units
Distribution: Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.
Product codes and lots: Lot Numbers: 602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999

Product code GXI

K034012Class IISmith & Nephew RF Denervation Probes & RF CannulaeSmith & Nephew, Inc. / cleared 2004-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)