Recall Z-0375-2007 ยท GDW Staple, Implantable
Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)
| Date | Feb 1, 2007 (initiated Dec 27, 2006) |
| Status | Terminated |
| Reason | Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050610 | SALUTE FIXATION SYSTEM Davol Inc., Sub. C. R. Bard, Inc., May 25, 2005 |