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
    36468
  • Event Risk Class
    Class 3
  • Event Number
    Z-0068-2007
  • Event Date Posted
    2006-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48700
  • 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
    skin graft - Product Code MGR
  • Reason
    Product ph out of specification.
  • Action
    Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.

Device

Organogenesis Apligraf
  • Model / Serial
    LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145   LOT:GS0609.05.02.1A  Unit Numbers: 197, 198
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Apligraf (Graftskin)
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

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