Events

Recall of Organognesis 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
    53458
  • Event Risk Class
    Class 2
  • Event Number
    Z-0181-2010
  • Event Date Posted
    2009-11-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85558
  • 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
    Unit contaminated with staphylococcus epidermidis.
  • Action
    Organogenesis, Inc. initiated a recall notification dated September 28, 2009 via fax to Physicians asking for return of unused affected product. If the unit was used, Physicians are advised to use standard wound care precautions to assure the safety of the patient. Users were asked to acknowledge receipt by completing and returning the notification to the firm. For further information, contact Organogenesis, Inc. at 1-888-432-5232.

Device

Organognesis Apligraf
  • Model / Serial
    Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009.  Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. || Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

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