Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andov
FDA device recall Z-1105-2007 · posted 2007-08-02 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc Endoscopy Division
- Reason for recall
- Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.
- Action taken
- Firm sent notification letters to consignees via overnight FedEx on 10/12-13/04. International customers were notified via letter on 11/10/04. Customers were asked to return footswitches for a replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWQ
- Quantity affected
- 274 units.
- Distribution
- Product sent to distributors nationwide and to the following countries: Australia, Austria, Canada, China, Germany, Italy, Japan, and Taiwan.
- Date initiated
- 2004-10-12
- Date posted
- 2007-08-02
- Date terminated
- 2007-08-02
- Location
- Oklahoma City, OK
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIVEX SYSTEM (K032387) | Smith & Nephew, Inc. | 2003-10-29 |