FDA Medical Device Recalls (openFDA)
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)
- Recall number
- Z-0375-2007
- 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)
- Status
- Terminated
- Initiated
- 2006-12-27
- Posted
- 2007-02-01
- Terminated
- 2016-07-06
- 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K050610"]
- PMA numbers
- not on file
- Product code
- GDW
- Firm FEI
- 1213643
- Firm city
- Cranston
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28