FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270
- Recall number
- Z-0662-2007
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Part Number: 7210270
- Status
- Terminated
- Initiated
- 2007-01-19
- Posted
- 2007-03-29
- Terminated
- 2008-01-18
- Reason
- Product is non-sterile but labeled incorrectly as sterile.
- Root cause
- Other
- Action
- Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
- Quantity
- 56 units
- Distribution
- Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.
- Lot, serial or model codes
- Lot Numbers: 602549,602550, 602846, 602847
- 510(k) numbers
- ["K034012"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28