Events

Recall of Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith and Nephew Wound Management (La Jolla).

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
    26327
  • Event Risk Class
    Class 2
  • Event Number
    Z-0904-03
  • Event Initiated Date
    2003-05-02
  • Event Date Posted
    2003-06-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27513
  • 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
    Dressing, Wound And Burn, Interactive - Product Code MGR
  • Reason
    Did not meet finished device specifications for the dna criteria.
  • Action
    Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.

Device

Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..

Manufacturer

Smith and Nephew Wound Management (La Jolla)
  • Manufacturer Address
    Smith and Nephew Wound Management (La Jolla), 10933 N Torrey Pines Road, Ste 200, San Diego CA 92037
  • Source
    USFDA