Recall Z-1267-2007 ยท GDW Staple, Implantable
Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
| Date | Sep 27, 2007 (initiated Jul 16, 2007) |
| Status | Terminated |
| 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 whi |
| 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 |
| 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 |