Recall Z-0663-2007 ยท GXI Probe, Radiofrequency Lesion
Smith & Nephew, Inc. Endoscopy Division
RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210271
| Date | Mar 29, 2007 (initiated Jan 19, 2007) |
| Status | Terminated |
| 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 | 338 units |
| Distribution | Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K034012 | SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE Smith & Nephew, Inc., Mar 16, 2004 |