Events

Recall of Device Recall Davol Salute Fixation Reusable Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Davol, Inc., Sub. C. R. Bard, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38634
  • Event Risk Class
    Class 2
  • Event Number
    Z-1266-2007
  • Event Initiated Date
    2007-07-16
  • Event Date Posted
    2007-09-27
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fixation Reusable Handle - Product Code GDW
  • 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.

Device

Device Recall Davol Salute Fixation Reusable Handle
  • Model / Serial
    All Serial Numbers
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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
  • Product Description
    Davol Salute Fixation Reusable Handle || Item Code: 0113024-Product Code 9113024 (Refurbished)
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • Manufacturer Address
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Sockanossett Crossroad, Cranston RI 02920
  • Source
    USFDA