Z-0375-2007

Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal...

Name: Z-0375-2007 Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal...
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2006-12-27
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2006-12-27 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or... on 2006-12-27. The reason FDA records is "Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0375-2007
Status: Terminated
Initiated: 2006-12-27
Posted: 2007-02-01
Terminated: 2016-07-06
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)
Product code: GDW Staple, Implantable
Reason for recall: Inadequate directions for use in the Salute System. Labeling -Revised to provide updated instructions for use and proper servicing
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All serial numbers

Product code GDW

K050610Class IISalute Fixation SystemDavol Inc., Sub. C. R. Bard, Inc. / cleared 2005-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)