Recall Z-0374-2007 ยท GDW Staple, Implantable
Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(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 |