FDA Medical Device Recalls (openFDA)
Davol, Inc., Sub. C. R. Bard, Inc.: Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
- Recall number
- Z-1267-2007
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Product
- Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
- Status
- Terminated
- Initiated
- 2007-07-16
- Posted
- 2007-09-27
- Terminated
- 2018-08-16
- Reason
- Malformed constructs (straight shots) may form causing injury to user/patient
- Root cause
- Device Design
- Action
- Davol issued recall letter notification on 7/16/07 via Federal Express. Sales of the disposable cartridges ceased July 31, 2007. Cartridges will not be requested to be returned to Davol. Customer requests to return cartridges will be managed on an account-by-account basis. A reminder Second Letter issued July 23,2007 as a follow-up to the letter of July 16, 2007. The second stage will be a series of three letters to customers following the cessation of disposable cartridge sales and to recall the re-usable handles. A Stock Status form will be provided to customers to inventory the product which they are returning. The Stock Status form will be used to document the handles being returned. In the event that the customer cannot locate one or more handles. All handles will be returned to Cranston and will be dispositioned. Account verification for the number of handles returned from the account will be performed. No verification testing will be performed on returned handles unless a formal complaint has been registered for a handle.
- Quantity
- 4,242 shafts
- Distribution
- Worldwide-USA and Canada, Austria, Switzerland, Spain, Sweden, United Kingdom, Italy,Portugal, Greece,Holland, South Africa, Israel, Japan, Belgium, Denmark, Finland, France, and Germany
- 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