BEUDAMED
    FDA Recall Terminated

    Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished)

    Recall: Z-1268-2007 · Initiated July 16, 2007

    Recall

    Recall Number
    Z-1268-2007
    Event Number
    38634
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 16, 2007
    Posted
    September 27, 2007
    Terminated
    August 16, 2018
    Address
    100 Sockanossett Crossroad, Cranston, RI, 02920

    Description

    Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished)

    Reason

    Malformed constructs (straight shots) may form causing injury to user/patient

    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.

    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

    Quantity

    1,026 shafts