Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Refe
FDA device recall Z-0374-2007 · posted 2007-02-01 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
- Action taken
- Davol notified users by a first letter on 12/27/06 providng a introductory letter explaining the Enhanced Servicing Program and changes made to the IFU (re: servicing, tip inspection, end of wire, and test fire protocol). A second letter will issue to accounts to identifying the serial number to be serviced and returned to Davol.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 4787 (includes both types)
- Distribution
- Worldwide, including USA, Austria, Italy, Israel, Finland, Switzerland, Portugal, Japan, France, Spain, Greece, Belgium, Germany, Sweden, Holland, Denmark, UK, and South Africa.
- Date initiated
- 2006-12-27
- Date posted
- 2007-02-01
- Date terminated
- 2016-07-06
- Location
- Cranston, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SALUTE FIXATION SYSTEM (K050610) | Davol Inc., Sub. C. R. Bard, Inc. | 2005-05-25 |