| Class 1 Device Recall Smith & Nephew | |
Date Initiated by Firm | January 19, 2007 |
Date Posted | March 29, 2007 |
Recall Status1 |
Terminated 3 on January 18, 2008 |
Recall Number | Z-0664-2007 |
Recall Event ID |
37232 |
510(K)Number | K034012 |
Product Classification |
Probe, Radiofrequency Lesion - Product Code GXI
|
Product | RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210272 |
Code Information |
Lot Numbers: 602543, 602570, 602571, 602850, 603000 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
|
For Additional Information Contact | Jason Bilobram 978-474-6332 |
Manufacturer Reason for Recall | Product is non-sterile but labeled incorrectly as sterile. |
FDA Determined Cause 2 | Other |
Action | Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007 |
Quantity in Commerce | 103 units |
Distribution | Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, and South Africa. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = GXI
|
|
|
|