RF Denervation Probe, 5cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the t
FDA device recall Z-0662-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- Product is non-sterile but labeled incorrectly as sterile.
- Action taken
- Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
- Root cause
- Other
- Status
- Terminated
- Product code
- GXI
- Quantity affected
- 56 units
- Distribution
- Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa.
- Date initiated
- 2007-01-19
- Date posted
- 2007-03-29
- Date terminated
- 2008-01-18
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K034012) | Smith & Nephew, Inc. | 2004-03-16 |