Events

Recall of Device Recall 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
    57824
  • Event Risk Class
    Class 2
  • Event Number
    Z-1746-2011
  • Event Initiated Date
    2011-01-30
  • Event Date Posted
    2011-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97509
  • 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
    burn and wound dressing - Product Code MGR
  • Reason
    Product sterility compromised.
  • Action
    Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis

Device

Device Recall Organogenesis Apligraf
  • Model / Serial
    Lot Number GS1012.28.05.2A Unit Numbers: 2, 5, 6, 7,8, 9,10, 11, 12, 13, 14, 15,16, 17,18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29, 31, 32, 34, 36, 37, 38, 39, 40, 41, 42,43, 44, 45,46, 50,51, 52, 53, 55, 56, 69 ,135, 200
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    nationwide.
  • Product Description
    Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
  • Manufacturer
    Organogenesis, Inc.

Manufacturer

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