Events

Recall of Organogenesis Apligraf

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Organogenesis, 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
    56543
  • Event Risk Class
    Class 2
  • Event Number
    Z-2589-2010
  • Event Initiated Date
    2010-08-02
  • Event Date Posted
    2010-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93893
  • 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
    Wound and Burn Interactive Dressing - Product Code MGR
  • Reason
    Product is contaminated with a yeast identified as pseudozyma antarctica.
  • Action
    Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.

Device

Organogenesis Apligraf
  • Model / Serial
    Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.
  • Product Description
    Apligraf is supplied as a living, bi-layered skin substitute. || Article Number: GS100 || Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

Organogenesis, Inc.
  • Manufacturer Address
    Organogenesis, Inc., 150 Dan Road, Canton MA 02021-2820
  • Source
    USFDA